The full value CRO
Evidenze is more than a full service CRO, is a full value CRO with Global reach.
Unlike traditional 'full-service' CROs, we go beyond execution.
Our 'Full Value' approach combines deep expertise, cutting-edge technology, and strategic insights to ensure the success of your investigation and product launch by accelerating your trials, optimizing costs, and providing you with tailored strategic consultancy and regulatory approach.
With Evidenze you don’t just complete your study, you maximize its impact.
Why us?
Full value CRO means more than services, means results.
It means generating scientific evidence and transforming it into knowledge in order to improve clinical practice and add value to the health sector.
Let’s move beyond Full Service
Unlock Full Value.
Wide experience in different
therapeutic areas.
Oncology
Click on your area of interest
Discover how Evidenze CRO supports biotechs and Small & Medium Pharma with tailor-made solutions
Core Services
A partner from beginning to end
Study Start-up
Clinical
Operations
EVIDENZE STUDY-STARTUP
Study Start-up
Regulatory knowledge and Experience
We provide comprehensive coordination of regulatory processes for clinical study approvals, ensuring full compliance with current regulations.
Our efficient management shortens timelines to study initiation, optimizing execution from the very first stage.
Services
Preparing and obtaining essential documents: Protocol, Patient Information Sheet / Informed Consent (PIS/IC), Preparation of study files TMF / ISF.
Application for authorization to health authorities (national and regional) and ethics committees.
Negotiation and signature of contracts.
Identification and selection of sites.
Management of amendments.
Processing of the civil liability insurance policy.
EVIDENZE CLINICAL OPERATIONS
Clinical Operations
Optimizing Clinical Operations Through Expertise in Key Therapeutic Areas
We drive operational efficiency in clinical studies through coordinated, results-focused management, ensuring high quality standards.
Our extensive experience across key therapeutic areas allows us to anticipate challenges and optimize each study stage with specialized solutions.
Services
Management of sites and investigators.
On site and/or remote monitoring visits.
Secondary and telephone monitoring activities.
Follow-up of sites and contacts with the investigators, encouraging recruitment
Follow-up and resolution of queries
Management of Investigational Products: accountability, destruction.
Management of biological samples with the appropriate central laboratory.
Creation and maintenance of files.
Management of SAEs.
Technological Tools
Resourcing & Project Management
EVIDENZE Technological Tools
Technological Tools
Empowering Clinical Research with Advanced Technical Capabilities and Digital Solutions
We possess strong technical capabilities and a suite of digital applications specifically designed for clinical research.
Our technological solutions enable efficient, traceable, and secure study management, empowering data-driven decision-making in real-time.
Services
eCRF: Electronic Case Report Form.
ePRO: Electronic Patient Reported Outcomes.
eTMF/eISF: Electronic Trial Master file
eDiary: Electronic patient diary.
eConsent: Electronic informed consent.
eRND: Electronic randomization.
IWRS: Investigational Product Management
EVIDENZE RESOURCING & PROJECT MANAGEMENT
Resourcing & Project Management
Expert Project Management in Clinical Research led by a Senior Team
We have a strong track record and extensive experience in clinical research project management, led by a highly skilled senior team.
Our expertise allows us to efficiently manage projects, ensuring the achievement of deadlines and objectives at every stage of the study.
Services
Staff search and screening.
Databases of candidates to hold different positions of CTAs, CRAs and CTLs.
Contract management.
Global coordination and management of the studies.
Training, coordination and monitoring of the project team.
Quality and GCP compliance.
Communication with all parties involved.
Support and resolution of incidents.
Organization of investigators' meetings.
Data Management
& Biostatistics
Medical Writing
EVIDENZE DATA MANAGEMENT & BIOSTATISTICS
Data Management & Biostatistics
Advanced Data Management and Statistical Solutions for Clinical Research
We provide advanced data management and statistical solutions, ensuring the integrity and precise analysis of information in every clinical study.
Our approach is based on cutting-edge tools and efficient processes to optimize decision-making and ensure reliable results.
Services
CDISC STDM data sets.
CDISC standards: ADaM-/SDTM structure.
Programming of statistical analyses in SAS and R.
Creation and management of SAS, MedRa, Oracle, SPSS, SQL Server databases.
Validation and cleaning of databases.
HTA expert consulting services.
Data management/conversion.
Coding with medical dictionaries.
Sample size justification.
Statistical analysis.
Statistical report.
Systematic reviews and meta-analysis.
Analysis of surveys: opinion, quantitative, qualitative, etc.
Statistical training (courses, conferences, etc.)
EVIDENZE MEDICAL WRITING
Medical Writing
Expert Medical Writing Services Focused on Quality and Compliance
We provide scientific advisory and medical writing services focused on quality and expertise, ensuring precise and clear documents throughout all stages of the clinical study.
Our team of experts ensures regulatory compliance and high standards in every deliverable.
Services
Scientific-technical advice.
Drafting proposals of studies (from Phase 1 to Phase 4 and non-interventional studies o RWE studies).
Scientific/medical writing of protocols.
Design of Case Report Forms.
Writing of final reports and interpretation of results.
Writing of scientific articles.
Drafting of congress publications and communications.
Drafting of product monographs.
Literature searches and reviews.
Pharmacovigilance
QA Audits & Consultancy
EVIDENZE PHARMACOVIGILANCE
Pharmacovigilance
Expert Pharmacovigilance Management Focused on Patient Safety and Compliance
We provide high-quality pharmacovigilance management, focused on patient safety and regulatory compliance.
Our expert team ensures continuous monitoring and effective risk management throughout the product lifecycle.
Services
Safety database.
Evaluation of SAEs and SUSARs.
Expeditious reporting.
Drafting of DSUR and PSUR.
Review of the protocol safety section.
Writing of safety agreements.
Reconciliation of database.
EVIDENZE QA audits and consultancy
QA Audits and Consultancy
Quality that adds value
At Evidenze, we have a highly specialized quality team committed to upholding the highest standards at every stage of the clinical study.
Our expertise ensures continuous improvement and excellence in quality management across all processes, and we are accredited by leading pharmaceutical companies.
Services
Audits for approval of suppliers (GCP, GMP and GDP).
Audits to the study file at the sponsor’s/CRO’s offices.
Audits to the study file at the site.
Internal audits (GCP, GMP and GDP).
Audits to computer systems GCP / GMP (GAMP 5 / FDA CFR 21 Part 11).
Training in GCP and audits.
Consultancy specialized in GCP quality systems with a wide experience in all therapeutic areas.
Digital Health
Patient Support
EVIDENZE Digital Health
Digital Health
Consultancy and innovation to lead the transformation towards a data-driven CRO under the European Health Data Space (EHDS) framework.
in R&D
and developments in Europe
by the European Union
Innovation projects and Pre-Commercial Procurement (PCP).
Purchase based on outcomes and Public Procurement of Innovation (PPI).
Consultancy and innovation for pharmaceutical companies.
Innovation of healthcare routes.
eHealth solutions developments.
lue-based healthcare.
Support apps for doctors, patients and telemedicine.
We speed up innovation in health and implement it.
Innovation projects and Pre-Commercial Procurement (PCP).
Purchase based on outcomes and Public Procurement of Innovation (PPI).
Consultancy and innovation for pharmaceutical companies.
Innovation of healthcare routes.
eHealth solutions developments.
lue-based healthcare.
Support apps for doctors, patients and telemedicine.
We work in different areas such as m-health, consultancy, healthcare processes, patient journey, co-creation of platforms. All our solutions have the capacity to integrate in the information systems of hospital or state centers.
We work in different areas such as m-health, consultancy, healthcare processes, patient journey, co-creation of platforms.
All our solutions have the capacity to integrate in the information systems of hospital or state centers.
EVIDENZE Patient Support
Patient Support
We develop home health services in clinical research and in the environment of patient-oriented programs.
calls
home visits
analyses
helped
Accompany and
empower at all times
and in any place
services
We provide patients with the tools they need to understand their disease, improve treatment compliance, and receive the necessary home services from healthcare professionals.
We provide patients with the tools they need to understand their disease, improve treatment compliance, and receive the necessary home services from healthcare professionals.
This translates into patient empowerment and consequently an improved sustainability of the healthcare system.
- Nursing Call Center
- Incoming calls
- HCP availability
- Helpline
- Home delivery
- Medical equipment transport
- Nurse Delivery
outgoing calls from health professionals:
- Nurses
- Nutritionists
- Physical therapists
- Psychologists
- Physicians
- Social workers
- Home or hospital training in diseases and products
- Home training in self-administration
- Home administration of drugs
- Home collection and analysis of biological samples
- Patient accompaniment and transport
- Patient access to clinical trials
- Patient trial compliance (home delivery of research product, home assistance)
- Nursing support at research centers
- Disposal of investigational product
- Calibration of medical devices
- Reimbursement of patient expenses
- For health professionals
- For patients
- For pharmacies
Scientific Communication
Market Access
EVIDENZE Scientific communication
Scientific Communication
Where science speaks with purpose.
In a Full Value CRO, data alone isn’t enough. To make an impact, science must connect with regulators, with physicians, with patients. That’s where we come in.
Scientific Communication is more than content creation. It’s a strategic service that transforms complex evidence into meaningful messages, creating the bridge from clinical research to real-world application.
Here's how we make science speak
Click on the buttons to know more
Strategic
Scientific
Narratives
Strategic
Scientific
Narratives
Strategic
Scientific
Narratives
Think of us as translators between data and decisions
We distill clinical and real-world evidence into powerful stories that inspire trust and guide decision-making.
From early development to market launch, we help our clients build a solid scientific backbone aligned with brand strategy, compliant with regulation, and designed for clarity.
What we deliver?
Scientific
Engagement
Programs
Scientific
Engagement
Programs
Scientific
Engagement
Programs
We don’t push information. We spark meaningful connections.
We design and execute tailored engagement strategies that educate, activate, and elevate medical audiences.
Whether it’s a disease awareness campaign, an educational initiative, or an immersive KOL experience. We make every interaction count.
What we deliver?
Medical
Positioning &
Go-to-Market Support
Medical
Positioning &
Go-to-Market Support
Medical
Positioning &
Go-to-Market Support
We make sure the science leads and lands.
We work side-by-side with medical and marketing teams to build positioning strategies that differentiate and resonate.
From clinical value to competitive edge, we help shape the scientific story that supports every launch.
What we deliver?
KOL Engagement &
Consensus
Building
KOL Engagement &
Consensus
Building
KOL Engagement &
Consensus
Building
Collaboration is our catalyst for credibility.
We help clients identify and connect with the right voices to amplify credibility and gain insights that matter.
Through co-creation, consensus, and expert dialogue, we turn scientific leadership into strategic advantage.
What we deliver?
Scientific
Omnichannel
Communication
Scientific
Omnichannel
Communication
Scientific
Omnichannel
Communication
From publication to podcast, we build science that travels.
We turn insights into impactful, channel-ready content from scientific visuals to AI-powered tools.
Every asset is designed to engage, educate and empower wherever the audience is, and however they prefer to learn.
What we deliver?
Think of us as translators between data and decisions
We distill clinical and real-world evidence into powerful stories that inspire trust and guide decision-making.
From early development to market launch, we help our clients build a solid scientific backbone aligned with brand strategy, compliant with regulation, and designed for clarity.
What we deliver?
We don’t push information. We spark meaningful connections.
We design and execute tailored engagement strategies that educate, activate, and elevate medical audiences.
Whether it’s a disease awareness campaign, an educational initiative, or an immersive KOL experience. We make every interaction count.
What we deliver?
We make sure the science leads and lands.
We work side-by-side with medical and marketing teams to build positioning strategies that differentiate and resonate.
From clinical value to competitive edge, we help shape the scientific story that supports every launch.
What we deliver?
Collaboration is our catalyst for credibility.
We help clients identify and connect with the right voices to amplify credibility and gain insights that matter.
Through co-creation, consensus, and expert dialogue, we turn scientific leadership into strategic advantage.
What we deliver?
From publication to podcast, we build science that travels.
We turn insights into impactful, channel-ready content from scientific visuals to AI-powered tools.
Every asset is designed to engage, educate and empower wherever the audience is, and however they prefer to learn.
What we deliver?
EVIDENZE Market Access
Market Access
We support you from early market access to value access with a personalized approach based on evidence.
Over 100 launchesin key therapeutic areas
Great diversityof innovative products
with new indications
Wide variety of healthcareinterventions and challenging
situations
Comprehensive strategies that elevate the impactof your products
Comprehensive strategies that elevate the impactof your products
HEOR & VALUE-BASED PROJECTS
- Disease burden models (clinical, economic, patient, healthcare)
- Value and social return on investment
- Economic evaluations/ economic impact of interventions
- Efficiency models of the healthcare process
- Multi-criteria decision analysis (MCDA)
- Consensus
- Think tank
- Perception studies of different stakeholders
- Evidence generation: systematic review, meta-analysis, indirect comparisons
- Excelling Health: Healthcare process mapping, Patient journey, Improvement implementation and KPI tracking
- RWE: Clinical, economic, patient (PROs) health outcomes, healthcare quality, disease burden, preference studies
MARKET ACCESS TOOLS & VALUE COMMUNICATION
- Value story
- National and regional value dossier
- Adaptation or de novo development of cost-effectiveness, cost-utility, cost-benefit, cost-minimization, budget impact models
- Critical reading of economic evaluations
- Cost and efficiency calculators
- Advisory board
- Objection handling documents
- Payer access tools
- Digital health tools
MARKET ACCESS STRATEGY
- Stakeholder mapping
- Positioning advisory board (blind/non-blind)
- Landscape analysis
- Market Access Insights
- Gap identification in evidence and action proposal
- Evaluation report simulations (HTA, PICO, IPT, GENESIS)
- Co-creation of the national and regional market access strategy
- Design and implementation of innovative agreements
- Value story
- National and regional value dossier
- Adaptation or de novo development of cost-effectiveness, cost-utility, cost-benefit, cost-minimization, budget impact models
- Critical reading of economic evaluations
- Cost and efficiency calculators
- Advisory board
- Objection handling documents
- Payer access tools
- Digital health tools
- Stakeholder mapping
- Positioning advisory board (blind/non-blind)
- Landscape analysis
- Market Access Insights
- Gap identification in evidence and action proposal
- Evaluation report simulations (HTA, PICO, IPT, GENESIS)
- Co-creation of the national and regional market access strategy
- Design and implementation of innovative agreements
- Disease burden models (clinical, economic, patient, healthcare)
- Value and social return on investment
- Economic evaluations/ economic impact of interventions
- Efficiency models of the healthcare process
- Multi-criteria decision analysis (MCDA)
- Consensus
- Think tank
- Perception studies of different stakeholders
- Evidence generation: systematic review, meta-analysis, indirect comparisons
- Excelling Health: Healthcare process mapping, Patient journey, Improvement implementation and KPI tracking
- RWE: Clinical, economic, patient (PROs) health outcomes, healthcare quality, disease burden, preference studies
Study Start-up
Clinical
Operations
Technological Tools
Resourcing & Project Management
Data Management
& Biostatistics
Medical Writing
EVIDENZE STUDY-STARTUP
Study Start-up
Regulatory knowledge and Experience
We provide comprehensive coordination of regulatory processes for clinical study approvals, ensuring full compliance with current regulations.
Our efficient management shortens timelines to study initiation, optimizing execution from the very first stage.
Services
Preparing and obtaining essential documents: Protocol, Patient Information Sheet / Informed Consent (PIS/IC), Preparation of study files TMF / ISF.
Application for authorization to health authorities (national and regional) and ethics committees.
Negotiation and signature of contracts.
Identification and selection of sites.
Management of amendments.
Processing of the civil liability insurance policy.
EVIDENZE CLINICAL OPERATIONS
Clinical Operations
Optimizing Clinical Operations Through Expertise in Key Therapeutic Areas
We drive operational efficiency in clinical studies through coordinated, results-focused management, ensuring high quality standards.
Our extensive experience across key therapeutic areas allows us to anticipate challenges and optimize each study stage with specialized solutions.
Services
Management of sites and investigators.
On site and/or remote monitoring visits.
Secondary and telephone monitoring activities.
Follow-up of sites and contacts with the investigators, encouraging recruitment
Follow-up and resolution of queries
Management of Investigational Products: accountability, destruction.
Management of biological samples with the appropriate central laboratory.
Creation and maintenance of files.
Management of SAEs.
EVIDENZE Technological Tools
Technological Tools
Empowering Clinical Research with Advanced Technical Capabilities and Digital Solutions
We possess strong technical capabilities and a suite of digital applications specifically designed for clinical research.
Our technological solutions enable efficient, traceable, and secure study management, empowering data-driven decision-making in real-time.
Services
eCRF: Electronic Case Report Form.
ePRO: Electronic Patient Reported Outcomes.
eTMF/eISF: Electronic Trial Master file
eDiary: Electronic patient diary.
eConsent: Electronic informed consent.
eRND: Electronic randomization.
IWRS: Investigational Product Management
EVIDENZE RESOURCING & PROJECT MANAGEMENT
Resourcing & Project Management
Expert Project Management in Clinical Research led by a Senior Team
We have a strong track record and extensive experience in clinical research project management, led by a highly skilled senior team.
Our expertise allows us to efficiently manage projects, ensuring the achievement of deadlines and objectives at every stage of the study.
Services
Staff search and screening.
Databases of candidates to hold different positions of CTAs, CRAs and CTLs.
Contract management.
Global coordination and management of the studies.
Training, coordination and monitoring of the project team.
Quality and GCP compliance.
Communication with all parties involved.
Support and resolution of incidents.
Organization of investigators' meetings.
EVIDENZE DATA MANAGEMENT & BIOSTATISTICS
Data Management & Biostatistics
Advanced Data Management and Statistical Solutions for Clinical Research
We provide advanced data management and statistical solutions, ensuring the integrity and precise analysis of information in every clinical study.
Our approach is based on cutting-edge tools and efficient processes to optimize decision-making and ensure reliable results.
Services
CDISC STDM data sets.
CDISC standards: ADaM-/SDTM structure.
Programming of statistical analyses in SAS and R.
Creation and management of SAS, MedRa, Oracle, SPSS, SQL Server databases.
Validation and cleaning of databases.
HTA expert consulting services.
Data management/conversion.
Coding with medical dictionaries.
Sample size justification.
Statistical analysis.
Statistical report.
Systematic reviews and meta-analysis.
Analysis of surveys: opinion, quantitative, qualitative, etc.
Statistical training (courses, conferences, etc.)
EVIDENZE MEDICAL WRITING
Medical Writing
Expert Medical Writing Services Focused on Quality and Compliance
We provide scientific advisory and medical writing services focused on quality and expertise, ensuring precise and clear documents throughout all stages of the clinical study.
Our team of experts ensures regulatory compliance and high standards in every deliverable.
Services
Scientific-technical advice.
Drafting proposals of studies (from Phase 1 to Phase 4 and non-interventional studies o RWE studies).
Scientific/medical writing of protocols.
Design of Case Report Forms.
Writing of final reports and interpretation of results.
Writing of scientific articles.
Drafting of congress publications and communications.
Drafting of product monographs.
Literature searches and reviews.
Pharmacovigilance
QA Audits & Consultancy
Digital Health
Patient Support
Scientific Communication
Market Access
EVIDENZE PHARMACOVIGILANCE
Pharmacovigilance
Expert Pharmacovigilance Management Focused on Patient Safety and Compliance
We provide high-quality pharmacovigilance management, focused on patient safety and regulatory compliance.
Our expert team ensures continuous monitoring and effective risk management throughout the product lifecycle.
Services
Safety database.
Evaluation of SAEs and SUSARs.
Expeditious reporting.
Drafting of DSUR and PSUR.
Review of the protocol safety section.
Writing of safety agreements.
Reconciliation of database.
EVIDENZE QA audits and consultancy
QA Audits and Consultancy
Quality that adds value
At Evidenze, we have a highly specialized quality team committed to upholding the highest standards at every stage of the clinical study.
Our expertise ensures continuous improvement and excellence in quality management across all processes, and we are accredited by leading pharmaceutical companies.
Services
Audits for approval of suppliers (GCP, GMP and GDP).
Audits to the study file at the sponsor’s/CRO’s offices.
Audits to the study file at the site.
Internal audits (GCP, GMP and GDP).
Audits to computer systems GCP / GMP (GAMP 5 / FDA CFR 21 Part 11).
Training in GCP and audits.
Consultancy specialized in GCP quality systems with a wide experience in all therapeutic areas.
EVIDENZE Digital Health
Digital Health
Consultancy and innovation to lead the transformation towards a data-driven CRO under the European Health Data Space (EHDS) framework.
in R&D
and developments in Europe
by the European Union
Innovation projects and Pre-Commercial Procurement (PCP).
Purchase based on outcomes and Public Procurement of Innovation (PPI).
Consultancy and innovation for pharmaceutical companies.
Innovation of healthcare routes.
eHealth solutions developments.
lue-based healthcare.
Support apps for doctors, patients and telemedicine.
We speed up innovation in health and implement it.
Innovation projects and Pre-Commercial Procurement (PCP).
Purchase based on outcomes and Public Procurement of Innovation (PPI).
Consultancy and innovation for pharmaceutical companies.
Innovation of healthcare routes.
eHealth solutions developments.
lue-based healthcare.
Support apps for doctors, patients and telemedicine.
We work in different areas such as m-health, consultancy, healthcare processes, patient journey, co-creation of platforms. All our solutions have the capacity to integrate in the information systems of hospital or state centers.
We work in different areas such as m-health, consultancy, healthcare processes, patient journey, co-creation of platforms.
All our solutions have the capacity to integrate in the information systems of hospital or state centers.
EVIDENZE Patient Support
Patient Support
We develop home health services in clinical research and in the environment of patient-oriented programs.
calls
home visits
analyses
helped
Accompany and
empower at all times
and in any place
services
We provide patients with the tools they need to understand their disease, improve treatment compliance, and receive the necessary home services from healthcare professionals.
We provide patients with the tools they need to understand their disease, improve treatment compliance, and receive the necessary home services from healthcare professionals.
This translates into patient empowerment and consequently an improved sustainability of the healthcare system.
- Nursing Call Center
- Incoming calls
- HCP availability
- Helpline
- Home delivery
- Medical equipment transport
- Nurse Delivery
outgoing calls from health professionals:
- Nurses
- Nutritionists
- Physical therapists
- Psychologists
- Physicians
- Social workers
- Home or hospital training in diseases and products
- Home training in self-administration
- Home administration of drugs
- Home collection and analysis of biological samples
- Patient accompaniment and transport
- Patient access to clinical trials
- Patient trial compliance (home delivery of research product, home assistance)
- Nursing support at research centers
- Disposal of investigational product
- Calibration of medical devices
- Reimbursement of patient expenses
- For health professionals
- For patients
- For pharmacies
EVIDENZE Scientific communication
Scientific Communication
Where science speaks with purpose.
In a Full Value CRO, data alone isn’t enough. To make an impact, science must connect with regulators, with physicians, with patients. That’s where we come in.
Scientific Communication is more than content creation. It’s a strategic service that transforms complex evidence into meaningful messages, creating the bridge from clinical research to real-world application.
Here's how we make science speak
Click on the buttons to know more
Strategic
Scientific
Narratives
Strategic
Scientific
Narratives
Strategic
Scientific
Narratives
Think of us as translators between data and decisions
We distill clinical and real-world evidence into powerful stories that inspire trust and guide decision-making.
From early development to market launch, we help our clients build a solid scientific backbone aligned with brand strategy, compliant with regulation, and designed for clarity.
What we deliver?
Scientific
Engagement
Programs
Scientific
Engagement
Programs
Scientific
Engagement
Programs
We don’t push information. We spark meaningful connections.
We design and execute tailored engagement strategies that educate, activate, and elevate medical audiences.
Whether it’s a disease awareness campaign, an educational initiative, or an immersive KOL experience. We make every interaction count.
What we deliver?
Medical
Positioning &
Go-to-Market Support
Medical
Positioning &
Go-to-Market Support
Medical
Positioning &
Go-to-Market Support
We make sure the science leads and lands.
We work side-by-side with medical and marketing teams to build positioning strategies that differentiate and resonate.
From clinical value to competitive edge, we help shape the scientific story that supports every launch.
What we deliver?
KOL Engagement &
Consensus
Building
KOL Engagement &
Consensus
Building
KOL Engagement &
Consensus
Building
Collaboration is our catalyst for credibility.
We help clients identify and connect with the right voices to amplify credibility and gain insights that matter.
Through co-creation, consensus, and expert dialogue, we turn scientific leadership into strategic advantage.
What we deliver?
Scientific
Omnichannel
Communication
Scientific
Omnichannel
Communication
Scientific
Omnichannel
Communication
From publication to podcast, we build science that travels.
We turn insights into impactful, channel-ready content from scientific visuals to AI-powered tools.
Every asset is designed to engage, educate and empower wherever the audience is, and however they prefer to learn.
What we deliver?
Think of us as translators between data and decisions
We distill clinical and real-world evidence into powerful stories that inspire trust and guide decision-making.
From early development to market launch, we help our clients build a solid scientific backbone aligned with brand strategy, compliant with regulation, and designed for clarity.
What we deliver?
We don’t push information. We spark meaningful connections.
We design and execute tailored engagement strategies that educate, activate, and elevate medical audiences.
Whether it’s a disease awareness campaign, an educational initiative, or an immersive KOL experience. We make every interaction count.
What we deliver?
We make sure the science leads and lands.
We work side-by-side with medical and marketing teams to build positioning strategies that differentiate and resonate.
From clinical value to competitive edge, we help shape the scientific story that supports every launch.
What we deliver?
Collaboration is our catalyst for credibility.
We help clients identify and connect with the right voices to amplify credibility and gain insights that matter.
Through co-creation, consensus, and expert dialogue, we turn scientific leadership into strategic advantage.
What we deliver?
From publication to podcast, we build science that travels.
We turn insights into impactful, channel-ready content from scientific visuals to AI-powered tools.
Every asset is designed to engage, educate and empower wherever the audience is, and however they prefer to learn.
What we deliver?
EVIDENZE Market Access
Market Access
We support you from early market access to value access with a personalized approach based on evidence.
Over 100 launchesin key therapeutic areas
Great diversityof innovative products
with new indications
Wide variety of healthcareinterventions and challenging
situations
Comprehensive strategies that elevate the impactof your products
Comprehensive strategies that elevate the impactof your products
HEOR & VALUE-BASED PROJECTS
- Disease burden models (clinical, economic, patient, healthcare)
- Value and social return on investment
- Economic evaluations/ economic impact of interventions
- Efficiency models of the healthcare process
- Multi-criteria decision analysis (MCDA)
- Consensus
- Think tank
- Perception studies of different stakeholders
- Evidence generation: systematic review, meta-analysis, indirect comparisons
- Excelling Health: Healthcare process mapping, Patient journey, Improvement implementation and KPI tracking
- RWE: Clinical, economic, patient (PROs) health outcomes, healthcare quality, disease burden, preference studies
MARKET ACCESS TOOLS & VALUE COMMUNICATION
- Value story
- National and regional value dossier
- Adaptation or de novo development of cost-effectiveness, cost-utility, cost-benefit, cost-minimization, budget impact models
- Critical reading of economic evaluations
- Cost and efficiency calculators
- Advisory board
- Objection handling documents
- Payer access tools
- Digital health tools
MARKET ACCESS STRATEGY
- Stakeholder mapping
- Positioning advisory board (blind/non-blind)
- Landscape analysis
- Market Access Insights
- Gap identification in evidence and action proposal
- Evaluation report simulations (HTA, PICO, IPT, GENESIS)
- Co-creation of the national and regional market access strategy
- Design and implementation of innovative agreements
- Value story
- National and regional value dossier
- Adaptation or de novo development of cost-effectiveness, cost-utility, cost-benefit, cost-minimization, budget impact models
- Critical reading of economic evaluations
- Cost and efficiency calculators
- Advisory board
- Objection handling documents
- Payer access tools
- Digital health tools
- Stakeholder mapping
- Positioning advisory board (blind/non-blind)
- Landscape analysis
- Market Access Insights
- Gap identification in evidence and action proposal
- Evaluation report simulations (HTA, PICO, IPT, GENESIS)
- Co-creation of the national and regional market access strategy
- Design and implementation of innovative agreements
- Disease burden models (clinical, economic, patient, healthcare)
- Value and social return on investment
- Economic evaluations/ economic impact of interventions
- Efficiency models of the healthcare process
- Multi-criteria decision analysis (MCDA)
- Consensus
- Think tank
- Perception studies of different stakeholders
- Evidence generation: systematic review, meta-analysis, indirect comparisons
- Excelling Health: Healthcare process mapping, Patient journey, Improvement implementation and KPI tracking
- RWE: Clinical, economic, patient (PROs) health outcomes, healthcare quality, disease burden, preference studies
Study Start-up
Clinical
Operations
Technological Tools
Resourcing & Project Management
EVIDENZE STUDY-STARTUP
Study Start-up
Regulatory knowledge and Experience
We provide comprehensive coordination of regulatory processes for clinical study approvals, ensuring full compliance with current regulations.
Our efficient management shortens timelines to study initiation, optimizing execution from the very first stage.
Services
Preparing and obtaining essential documents: Protocol, Patient Information Sheet / Informed Consent (PIS/IC), Preparation of study files TMF / ISF.
Application for authorization to health authorities (national and regional) and ethics committees.
Negotiation and signature of contracts.
Identification and selection of sites.
Management of amendments.
Processing of the civil liability insurance policy.
EVIDENZE CLINICAL OPERATIONS
Clinical Operations
Optimizing Clinical Operations Through Expertise in Key Therapeutic Areas
We drive operational efficiency in clinical studies through coordinated, results-focused management, ensuring high quality standards.
Our extensive experience across key therapeutic areas allows us to anticipate challenges and optimize each study stage with specialized solutions.
Services
Management of sites and investigators.
On site and/or remote monitoring visits.
Secondary and telephone monitoring activities.
Follow-up of sites and contacts with the investigators, encouraging recruitment
Follow-up and resolution of queries
Management of Investigational Products: accountability, destruction.
Management of biological samples with the appropriate central laboratory.
Creation and maintenance of files.
Management of SAEs.
EVIDENZE Technological Tools
Technological Tools
Empowering Clinical Research with Advanced Technical Capabilities and Digital Solutions
We possess strong technical capabilities and a suite of digital applications specifically designed for clinical research.
Our technological solutions enable efficient, traceable, and secure study management, empowering data-driven decision-making in real-time.
Services
eCRF: Electronic Case Report Form.
ePRO: Electronic Patient Reported Outcomes.
eTMF/eISF: Electronic Trial Master file
eDiary: Electronic patient diary.
eConsent: Electronic informed consent.
eRND: Electronic randomization.
IWRS: Investigational Product Management
EVIDENZE RESOURCING & PROJECT MANAGEMENT
Resourcing & Project Management
Expert Project Management in Clinical Research led by a Senior Team
We have a strong track record and extensive experience in clinical research project management, led by a highly skilled senior team.
Our expertise allows us to efficiently manage projects, ensuring the achievement of deadlines and objectives at every stage of the study.
Services
Staff search and screening.
Databases of candidates to hold different positions of CTAs, CRAs and CTLs.
Contract management.
Global coordination and management of the studies.
Training, coordination and monitoring of the project team.
Quality and GCP compliance.
Communication with all parties involved.
Support and resolution of incidents.
Organization of investigators' meetings.
Data Management
& Biostatistics
Medical Writing
Pharmacovigilance
QA Audits & Consultancy
EVIDENZE DATA MANAGEMENT & BIOSTATISTICS
Data Management & Biostatistics
Advanced Data Management and Statistical Solutions for Clinical Research
We provide advanced data management and statistical solutions, ensuring the integrity and precise analysis of information in every clinical study.
Our approach is based on cutting-edge tools and efficient processes to optimize decision-making and ensure reliable results.
Services
CDISC STDM data sets.
CDISC standards: ADaM-/SDTM structure.
Programming of statistical analyses in SAS and R.
Creation and management of SAS, MedRa, Oracle, SPSS, SQL Server databases.
Validation and cleaning of databases.
HTA expert consulting services.
Data management/conversion.
Coding with medical dictionaries.
Sample size justification.
Statistical analysis.
Statistical report.
Systematic reviews and meta-analysis.
Analysis of surveys: opinion, quantitative, qualitative, etc.
Statistical training (courses, conferences, etc.)
EVIDENZE MEDICAL WRITING
Medical Writing
Expert Medical Writing Services Focused on Quality and Compliance
We provide scientific advisory and medical writing services focused on quality and expertise, ensuring precise and clear documents throughout all stages of the clinical study.
Our team of experts ensures regulatory compliance and high standards in every deliverable.
Services
Scientific-technical advice.
Drafting proposals of studies (from Phase 1 to Phase 4 and non-interventional studies o RWE studies).
Scientific/medical writing of protocols.
Design of Case Report Forms.
Writing of final reports and interpretation of results.
Writing of scientific articles.
Drafting of congress publications and communications.
Drafting of product monographs.
Literature searches and reviews.
EVIDENZE PHARMACOVIGILANCE
Pharmacovigilance
Expert Pharmacovigilance Management Focused on Patient Safety and Compliance
We provide high-quality pharmacovigilance management, focused on patient safety and regulatory compliance.
Our expert team ensures continuous monitoring and effective risk management throughout the product lifecycle.
Services
Safety database.
Evaluation of SAEs and SUSARs.
Expeditious reporting.
Drafting of DSUR and PSUR.
Review of the protocol safety section.
Writing of safety agreements.
Reconciliation of database.
EVIDENZE QA audits and consultancy
QA Audits and Consultancy
Quality that adds value
At Evidenze, we have a highly specialized quality team committed to upholding the highest standards at every stage of the clinical study.
Our expertise ensures continuous improvement and excellence in quality management across all processes, and we are accredited by leading pharmaceutical companies.
Services
Audits for approval of suppliers (GCP, GMP and GDP).
Audits to the study file at the sponsor’s/CRO’s offices.
Audits to the study file at the site.
Internal audits (GCP, GMP and GDP).
Audits to computer systems GCP / GMP (GAMP 5 / FDA CFR 21 Part 11).
Training in GCP and audits.
Consultancy specialized in GCP quality systems with a wide experience in all therapeutic areas.
Digital Health
Patient Support
Scientific Communication
Market Access
EVIDENZE Digital Health
Digital Health
Consultancy and innovation to lead the transformation towards a data-driven CRO under the European Health Data Space (EHDS) framework.
in R&D
and developments in Europe
by the European Union
Innovation projects and Pre-Commercial Procurement (PCP).
Purchase based on outcomes and Public Procurement of Innovation (PPI).
Consultancy and innovation for pharmaceutical companies.
Innovation of healthcare routes.
eHealth solutions developments.
lue-based healthcare.
Support apps for doctors, patients and telemedicine.
We speed up innovation in health and implement it.
Innovation projects and Pre-Commercial Procurement (PCP).
Purchase based on outcomes and Public Procurement of Innovation (PPI).
Consultancy and innovation for pharmaceutical companies.
Innovation of healthcare routes.
eHealth solutions developments.
lue-based healthcare.
Support apps for doctors, patients and telemedicine.
We work in different areas such as m-health, consultancy, healthcare processes, patient journey, co-creation of platforms. All our solutions have the capacity to integrate in the information systems of hospital or state centers.
We work in different areas such as m-health, consultancy, healthcare processes, patient journey, co-creation of platforms.
All our solutions have the capacity to integrate in the information systems of hospital or state centers.
EVIDENZE Patient Support
Patient Support
We develop home health services in clinical research and in the environment of patient-oriented programs.
calls
home visits
analyses
helped
Accompany and
empower at all times
and in any place
services
We provide patients with the tools they need to understand their disease, improve treatment compliance, and receive the necessary home services from healthcare professionals.
We provide patients with the tools they need to understand their disease, improve treatment compliance, and receive the necessary home services from healthcare professionals.
This translates into patient empowerment and consequently an improved sustainability of the healthcare system.
- Nursing Call Center
- Incoming calls
- HCP availability
- Helpline
- Home delivery
- Medical equipment transport
- Nurse Delivery
outgoing calls from health professionals:
- Nurses
- Nutritionists
- Physical therapists
- Psychologists
- Physicians
- Social workers
- Home or hospital training in diseases and products
- Home training in self-administration
- Home administration of drugs
- Home collection and analysis of biological samples
- Patient accompaniment and transport
- Patient access to clinical trials
- Patient trial compliance (home delivery of research product, home assistance)
- Nursing support at research centers
- Disposal of investigational product
- Calibration of medical devices
- Reimbursement of patient expenses
- For health professionals
- For patients
- For pharmacies
EVIDENZE Scientific communication
Scientific Communication
Where science speaks with purpose.
In a Full Value CRO, data alone isn’t enough. To make an impact, science must connect with regulators, with physicians, with patients. That’s where we come in.
Scientific Communication is more than content creation. It’s a strategic service that transforms complex evidence into meaningful messages, creating the bridge from clinical research to real-world application.
Here's how we make science speak
Click on the buttons to know more
Strategic
Scientific
Narratives
Strategic
Scientific
Narratives
Strategic
Scientific
Narratives
Think of us as translators between data and decisions
We distill clinical and real-world evidence into powerful stories that inspire trust and guide decision-making.
From early development to market launch, we help our clients build a solid scientific backbone aligned with brand strategy, compliant with regulation, and designed for clarity.
What we deliver?
Scientific
Engagement
Programs
Scientific
Engagement
Programs
Scientific
Engagement
Programs
We don’t push information. We spark meaningful connections.
We design and execute tailored engagement strategies that educate, activate, and elevate medical audiences.
Whether it’s a disease awareness campaign, an educational initiative, or an immersive KOL experience. We make every interaction count.
What we deliver?
Medical
Positioning &
Go-to-Market Support
Medical
Positioning &
Go-to-Market Support
Medical
Positioning &
Go-to-Market Support
We make sure the science leads and lands.
We work side-by-side with medical and marketing teams to build positioning strategies that differentiate and resonate.
From clinical value to competitive edge, we help shape the scientific story that supports every launch.
What we deliver?
KOL Engagement &
Consensus
Building
KOL Engagement &
Consensus
Building
KOL Engagement &
Consensus
Building
Collaboration is our catalyst for credibility.
We help clients identify and connect with the right voices to amplify credibility and gain insights that matter.
Through co-creation, consensus, and expert dialogue, we turn scientific leadership into strategic advantage.
What we deliver?
Scientific
Omnichannel
Communication
Scientific
Omnichannel
Communication
Scientific
Omnichannel
Communication
From publication to podcast, we build science that travels.
We turn insights into impactful, channel-ready content from scientific visuals to AI-powered tools.
Every asset is designed to engage, educate and empower wherever the audience is, and however they prefer to learn.
What we deliver?
Think of us as translators between data and decisions
We distill clinical and real-world evidence into powerful stories that inspire trust and guide decision-making.
From early development to market launch, we help our clients build a solid scientific backbone aligned with brand strategy, compliant with regulation, and designed for clarity.
What we deliver?
We don’t push information. We spark meaningful connections.
We design and execute tailored engagement strategies that educate, activate, and elevate medical audiences.
Whether it’s a disease awareness campaign, an educational initiative, or an immersive KOL experience. We make every interaction count.
What we deliver?
We make sure the science leads and lands.
We work side-by-side with medical and marketing teams to build positioning strategies that differentiate and resonate.
From clinical value to competitive edge, we help shape the scientific story that supports every launch.
What we deliver?
Collaboration is our catalyst for credibility.
We help clients identify and connect with the right voices to amplify credibility and gain insights that matter.
Through co-creation, consensus, and expert dialogue, we turn scientific leadership into strategic advantage.
What we deliver?
From publication to podcast, we build science that travels.
We turn insights into impactful, channel-ready content from scientific visuals to AI-powered tools.
Every asset is designed to engage, educate and empower wherever the audience is, and however they prefer to learn.
What we deliver?
EVIDENZE Market Access
Market Access
We support you from early market access to value access with a personalized approach based on evidence.
Over 100 launchesin key therapeutic areas
Great diversityof innovative products
with new indications
Wide variety of healthcareinterventions and challenging
situations
Comprehensive strategies that elevate the impactof your products
Comprehensive strategies that elevate the impactof your products
HEOR & VALUE-BASED PROJECTS
- Disease burden models (clinical, economic, patient, healthcare)
- Value and social return on investment
- Economic evaluations/ economic impact of interventions
- Efficiency models of the healthcare process
- Multi-criteria decision analysis (MCDA)
- Consensus
- Think tank
- Perception studies of different stakeholders
- Evidence generation: systematic review, meta-analysis, indirect comparisons
- Excelling Health: Healthcare process mapping, Patient journey, Improvement implementation and KPI tracking
- RWE: Clinical, economic, patient (PROs) health outcomes, healthcare quality, disease burden, preference studies
MARKET ACCESS TOOLS & VALUE COMMUNICATION
- Value story
- National and regional value dossier
- Adaptation or de novo development of cost-effectiveness, cost-utility, cost-benefit, cost-minimization, budget impact models
- Critical reading of economic evaluations
- Cost and efficiency calculators
- Advisory board
- Objection handling documents
- Payer access tools
- Digital health tools
MARKET ACCESS STRATEGY
- Stakeholder mapping
- Positioning advisory board (blind/non-blind)
- Landscape analysis
- Market Access Insights
- Gap identification in evidence and action proposal
- Evaluation report simulations (HTA, PICO, IPT, GENESIS)
- Co-creation of the national and regional market access strategy
- Design and implementation of innovative agreements
- Value story
- National and regional value dossier
- Adaptation or de novo development of cost-effectiveness, cost-utility, cost-benefit, cost-minimization, budget impact models
- Critical reading of economic evaluations
- Cost and efficiency calculators
- Advisory board
- Objection handling documents
- Payer access tools
- Digital health tools
- Stakeholder mapping
- Positioning advisory board (blind/non-blind)
- Landscape analysis
- Market Access Insights
- Gap identification in evidence and action proposal
- Evaluation report simulations (HTA, PICO, IPT, GENESIS)
- Co-creation of the national and regional market access strategy
- Design and implementation of innovative agreements
- Disease burden models (clinical, economic, patient, healthcare)
- Value and social return on investment
- Economic evaluations/ economic impact of interventions
- Efficiency models of the healthcare process
- Multi-criteria decision analysis (MCDA)
- Consensus
- Think tank
- Perception studies of different stakeholders
- Evidence generation: systematic review, meta-analysis, indirect comparisons
- Excelling Health: Healthcare process mapping, Patient journey, Improvement implementation and KPI tracking
- RWE: Clinical, economic, patient (PROs) health outcomes, healthcare quality, disease burden, preference studies
ESG Commitment is a Foundational Pillar Underpinning Quality Services and Operational Excellence
ESG Commitment is a Foundational Pillar Underpinning
Quality Services and Operational Excellence
ESG Overview
Evidenze is fully committed to integrating Environmental, Social, and Governance (ESG) principles into every aspect of its operations.
The Group aims to reduce resource consumption through digitalization and energy-efficient measures.
Policies are advanced to promote work-life balance and equal opportunities for all employees.
Comprehensive safety measures are implemented, with continuous input gathered from employees through engagement surveys.
Supplier compliance with safety and ethical standards is ensured.
ISO-certified processes are implemented to maintain the highest standards of safety and quality across its programs.
Standard Programs and Initiatives
Environmental
Objective to decrease energy and paper consumption by implementing digital processes and energy-efficient technologies
Registered with ECOVADIS to evaluate and benchmark our performance in sustainable development and corporate social responsibility
Social
Developing and communicating new employee policies throughout 2024, including a 'Right to Disconnect' protocol and a flexible working policy
Updating the Gender Equality Plan to be signed with the Works Council, ensuring equal opportunities for all employees
Conducting an engagement survey to assess employee satisfaction and identify areas for improvement in health and well-being
Engaged in pro-bono projects across business units leveraging unique know-how and capabilities
Governance
Established an internal whistleblower channel to encourage confidential reporting of safety concerns and unethical practices
Conducted comprehensive cyber-security training to safeguard company data and prevent breaches
Implemented supplier homologation processes to ensure compliance with safety and ethical standards across the supply chain
Adopted an ethics code that includes a strict anti-corruption and bribery policy to maintain transparency and integrity