Clinical Data Management 

DATA
 

Clinical Data Management

Clinical Data Management

 

At Excelya, data is at the heart of our clinical development strategy.

We ensure every stage of the process, from protocol design to regulatory submission, is driven by accurate, timely, and well governed data that supports confident decision making.

Stage 01

Protocol design

Stage 02

Well governed data

Stage 03

Regulatory submission

CDM
 

Clinical Data Management

Our Clinical Data Management Approach

 

A structured approach to accurate, compliant, and well governed clinical data across the trial lifecycle.

Read our case study

1

Data Collection at the Core

At Excelya, we recognize that accurate and efficient data collection is the foundation of every successful clinical trial. Our Data Management (DM) team places this at the center of all efforts.

2

End-to-End Robust Processes

We deliver comprehensive DM solutions tailored to the chosen Electronic Data Capture (EDC) system, ensuring flexibility and compliance throughout the trial lifecycle.

3

Collaborative and Stakeholder-Driven

Our processes are built on strong collaboration, engaging all stakeholders to maintain transparency, quality, and timely delivery.

 
 

Data Management in Numbers

At a Glance

 
 

90+ studies

since 2022, over the last 4 years

 

50+ clients

supported over the last 4 years

 

2 to 30+ years

of team member experience

 

6% PhDs

51% Post Grads and 43% Grads

 

25 to 30

projects per year

 

3/5 top EDC

expertise across leading platforms

 

Systems and Technologies

EDC Platform Expertise

 

Expertise across leading Electronic Data Capture platforms supporting efficient clinical data management.

Veeva Services logo for data management platform expertise

Veeva

Viedoc logo for electronic data capture platform expertise

Viedoc

Oracle Clinical One logo for clinical data management technology expertise

Oracle Clinical One

Global
 

Global team presence

5 countries

A distributed team supporting flexible data management delivery across key international hubs.

FranceNetherlandsGermanyGreeceIndia

 

Supporting scalable delivery across local and global project needs.

Map showing connected clinical data management sites across Europe and India.
DM

Data Management Philosophy

Excelya’s philosophy in data management

 

At Excelya, our Data Management team is deeply aware of the thousands of patients behind the data we process every day.

We know that each data point represents a life, and this strengthens our commitment to patient safety, data integrity, quality, and compliance, helping treatments reach patients faster.

Global expertise

100+ data experts worldwide

6%

PhD profiles

51%

postgraduate profiles

44%

graduate profiles

9+

years of average field experience

✓

Precise, timely, and compliant data solutions

Our experts apply their knowledge to deliver accurate data solutions. Our processes and documentation provide a strong regulatory framework while maintaining the flexibility needed to meet the unique and complex requirements of each clinical trial protocol.

DM

Data Management Solutions

Full Service & Standalone Data Management Solutions

Flexible models designed to support quality, compliance, reliability, and efficient clinical trial delivery.

1

Complete Ownership & Peace of Mind

Our Full Service and Standalone Data Management models take complete ownership of your data processes in-house, ensuring quality, compliance, and reliability for your trial and data teams.

2

Rapid eCRF Deployment

With our standard time plan approach, we help achieve eCRF go-live within 12 weeks, accelerating study start-up timelines.

3

Strategic EDC Alliances

We leverage robust processes and strategic partnerships with leading EDC providers to implement tailored data collection, cleaning, release, and archival infrastructure for each clinical trial.

4

Integrated Randomization & Supply Management

Our approach incorporates strategic considerations from clinical operations and medical teams, ensuring the best technology choices for seamless trial management.

5

Cross-Functional Collaboration

Collaboration with Medical Writing, Statistics, and Medical Affairs is embedded in our SOPs and practices, enabling early data strategy planning and preventing close-out challenges.

Clinical professional using a laptop for Clinical Data Management.
FSP

FSP Methodology

Functional Service Provider (FSP) for Data Management

One Proven FSP Methodology From Strategy to Scalable Execution

01

Proven Expertise Across Clinical Development

Excelya’s FSP methodology leverages our extensive experience across all clinical development functions, ensuring consistency and quality.

02

SOP-Driven Consistency

 

Every FSP engagement is guided by our robust SOPs, enabling us to deliver standardized processes while maximizing our expertise.

03

Tailored Strategies for Every Need

Whether your FSP requirements are large or small, our dedicated methodology team develops a customized strategy to fit your goals.

04

Efficient Team Seeding

 

Our DM team represents a highly skilled subset of our global workforce, ensuring efficient and effective deployment for each FSP setup.

05

Scalable Global Resource Pools

With strategic DM resource pools across Western and Eastern Europe, strengthened by a strong presence in India, we offer unmatched scalability.

06

Sponsor Tool Training & Process Integration

 

Training on sponsor tools and systems is a top priority. We also support developing FSP-specific processes for seamless delivery and platform consistency.

07

Governance & Performance Transparency

We work closely with you to define KPIs and governance frameworks, keeping you fully informed about performance and progress.

CDM

Clinical Data Management

Clinical Data Management,
implemented with care

Whatever your clinical data management needs, Excelya has a flexible option that can help you succeed.

1

Quality and innovation

A consistent high quality approach

Our team’s approach always has the same high level of quality: We develop proprietary and innovative solutions to upgrade deliverables and strengthen communications.

2

Flexible delivery model

Local support or global scale

 

With our international team, you can choose to work locally or scale up and run the project across onshore and offshore hubs globally. Our experts can close the gaps in your teams and capabilities through our flexible Resourcing model.

Operating Models

Three models of data management support

1

Resourcing

2

FSP

3

Full Service

Our data management support is available at three levels: Resourcing, FSP, and Full Service.

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Frequently Asked Questions

 
 

What is Clinical Data Management in clinical trials?

Clinical Data Management is the process of collecting, cleaning, validating, and preparing clinical trial data for analysis and regulatory submission. At Excelya, clinical data management supports every stage of the clinical development process, from protocol design to submission, with accurate, timely, and well governed data.

How does Excelya support clinical data management projects?

Excelya supports clinical data management projects through flexible delivery models adapted to each sponsor’s needs. Our data management team can provide Resourcing, Functional Service Provider, also known as FSP, or Full Service support, helping sponsors strengthen internal capabilities, scale globally, and maintain high quality delivery.

Which technologies does Excelya use for clinical data management?

Excelya’s clinical data experts work with advanced technologies and leading Electronic Data Capture systems. Our teams use Veeva Vault as a default system and also have expertise with Veeva, Viedoc, and Oracle Clinical One, enabling customized data management solutions that fit each sponsor’s existing setup.

Can Excelya provide local and global data management support?

Yes. Excelya offers both local and global clinical data management support through an international team spread across onshore and offshore hubs. This allows sponsors to work locally when needed or scale projects globally with flexible data management resources and expert support.

Why choose Excelya for Clinical Data Management?

Excelya combines clinical data expertise, advanced technologies, flexible delivery models, and international resourcing to support high quality trial delivery. Our approach helps sponsors improve deliverables, strengthen communication, close capability gaps, and make confident decisions based on reliable clinical data.