Clinical Biostatistics & Statistical Programming

Statistics & Programming

Your partner for clinical statistics and programming across every stage of your study.

Excelya S&P brings together experienced biostatisticians and statistical programmers to reliably collaborate with sponsors, from study design and statistical setup consultations to programming high-quality outputs, reporting and publication support.

Whether you need a dedicated expert, a flexible FSP team or a full-service CRO partner, we adapt our scope of activities to your project, your timelines and your operating model.

Across your study

Analysis

From descriptive analyses to complex analytical projects.

Study lifecycle

From study design to CSR review, including interim and exploratory or post-hoc analyses.

Study coverage

Support across Phase I to Phase IV, non-interventional studies, late phase and Real-World Evidence (RWE).

Project experience

Experience with pharmaceutical, biotechnology, medical device and cosmetics projects.

Integrated biometry

Integrated biometry offer combining Data Management, Statistics & Programming and Medical Writing.

CDISC

Dataset standardisation via a CDISC process compliant with submissions to the FDA, PMDA, NMPA and EMA.

RBQM

RBQM strategy and development.

Why Excelya S&P

Why partner with Excelya S&P?

Our delivery approach is built around transparent governance, regular communication and a clear definition of the scope of work. Sponsors benefit from stable points of contact, adapted profiles, low team turnover, validated internal programming tools and measurable quality indicators.

Historical experience

20+ years

Clients

100+

Number of years of experience

15+ years

Median: 16.7 and STD: 9.1

Tools

SAS Clinical Acceleration, Viya with Git and Repository, R and Pinnacle 21

Compliance

Audit trail and CDISC submission package

Statistics & Programming Team

Experienced, international Statistics & Programming team

Excelya S&P is an experienced international team of around 70 specialists across France, Germany, Greece and India, combining biostatistics, clinical statistical programming and CDISC expertise. The team supports clinical studies from planning through delivery, including DSMB activities and study reporting, helping sponsors address scientific and technical requirements through clear collaboration, efficient execution and high-quality standards.

Team strengths to highlight

Statisticians proficient in programming enable smoother connections between SAPs, analysis datasets, TLFs and quality control.

Programmers with a strong statistical background support better understanding of analysis objectives, data structure and output interpretation.

Broad study coverage spans Phase I to Phase IV, non-interventional studies, late phase research, RWE, and pharma, biotech, medical device and cosmetics environments.

Specialists

France & Germany 75%

Greece 15%

India 10%

Team composition

70% Statistical Programmers

30% Statisticians

Statistics & Programming lifecycle

Deliverables and activities across the study lifecycle

Sponsors can choose individual S&P bricks or the full package. Excelya can act as the project team, support the review of work produced by other providers or serve as an independent partner for DSMB activities.

Stage 01

Study design

Early involvement to consult on study design, endpoints, analysis strategy and statistical feasibility.

01Study design›

02Sample size›

03Protocol›

04Randomization›

05DM docs review›

06EDC Go Live›

07Statistical Analysis Plan›

08TLFs specification›

09Data extract›

10Analysis datasets (CDISC)›

11TLFs programming & QC›

12Dry run›

13Data snapshot›

14Data review›

15Database lock›

16Output delivery›

17Study report›

18Publication✓

Select a lifecycle stage to view its definition.

Integrated S&P collaboration

Collaboration with other departments

Coordinating Medical Writing, Data Management and sponsor teams, with integrated Biometry support when needed.

Medical Writing

Protocol input, SAP alignment, CSR interpretation and publication support.

Data Management

DM documentation review, EDC readiness, data review, data snapshot and database lock support.

Sponsor teams

Scope definition, regular review meetings, dry runs, output approval and decision-making.

Biometry model

Integrated Data Management, Statistics & Programming and Medical Writing support when a broader solution is needed.

Flexible S&P delivery

One-stop S&P provider with three operating modes

Excelya S&P can support sponsors through three operating modes: Resourcing, FSP and Full Service / Standalone. This gives sponsors the flexibility to choose the right level of ownership, governance and delivery model for each project.

Full Service / Standalone

Excelya-led delivery

Multiservice, associated with other Excelya departments (PM, CTA, CRA, DM, MW, …).

Standalone, contracting only with the Statistics & Programming team.

Using Excelya SOPs (SAP, TLF programming, …) and tools (SAS, R, …) on a deliverable model.

FSP

Flexible team delivery

Dedicated and flexible team assignment.

Using sponsor SOPs and tools on a deliverable model or FTE basis.

Resourcing

Dedicated expertise

Dedicated resources.

Using sponsor SOPs and tools, usually on an FTE basis.

One S&P partner.

Three ways to adapt ownership, governance and delivery to the project.

Submit your request

Frequently Asked Questions

What statistics and programming services does Excelya provide?

Excelya provides clinical biostatistics and statistical programming support across the study lifecycle. Services include CDISC analysis datasets, statistical analysis planning, submission package support, DSMB deliverables, real-world evidence (RWE) and non-interventional studies.

Can Excelya support individual statistical programming activities?

Yes. Sponsors can select individual Statistics & Programming services or a complete package, depending on their project requirements. Excelya can deliver specific activities, support the review of work produced by other providers or act as the project team.

How does Excelya support clinical trial data analysis?

Excelya combines statistical expertise with programming capabilities to support clinical trial analysis and reporting. Its activities include statistical analysis planning, CDISC analysis datasets and submission-related deliverables, with collaboration across Data Management and Medical Writing teams.

Does Excelya provide independent DSMB support?

Yes. Excelya can serve as an independent partner for Data Safety Monitoring Board (DSMB) activities. Sponsors can access this support as an individual service or alongside broader Statistics & Programming activities, depending on their study requirements.

ow does Excelya integrate biostatistics, Data Management and Medical Writing?

Excelya offers an integrated Biometry model combining Data Management, Statistics & Programming and Medical Writing. Collaboration covers protocol input, SAP alignment, EDC readiness, database lock support, clinical study report interpretation and publication support.