Custom Clinical Data Management Services
With solutions as unique as your trial and backed by our SOP‑led, quality‑by‑design approach, we keep your trial moving forward with accuracy, compliance, and efficiency.
- Protocol review and case report form (CRF) design through CDISC standards
- Certified database builders and medical coders (MedDRA and WHO‑DD)
- Design, testing, validation, and maintenance of 21 CFR Part 11 databases
- Advanced and methodical data review
Optimized Study Design & Analysis
Turn your data into actionable insights with our statistical expertise. From study design to analysis and publication, we help you achieve smarter, faster, and more impactful results.
- Programming, analyses, and eCRT packages to ICH GCP and CDISC standards
- Statistical analysis plans & mock‑up shells
- Sample size estimation, power calculations, and randomization
- Patient profile creation and narrative programming
- Clinical study report (CSR) input, including TLF production
The CRO That Meets You Where You Are
Wherever your trial and whatever the phase, we’re here. Our diverse team brings global infrastructure, local expertise, and personalized support to overcome challenges and drive success.
- Teams with years of experience across CROs, biotech, and pharma
- Dedicated specialists in 40+ locations operate across time zones
- Local experts deliver region‑specific solutions
- Complete data management for Phase I–IV and post‑marketing commitments
End‑to‑End Clinical Data Management Services
Our risk‑based methodology ensures quality and consistency from electronic data capture (EDC) system setup to data processing.
We use fully validated EDC systems, including Medidata Rave®, Zelta™, and other industry‑leading systems, for reliable and secure clinical trial data management.
Count on us to seamlessly integrate third‑party systems, including electronic patient‑reported outcomes (ePRO) and randomization and trial supply management (RTSM).
We tailor our adaptive delivery solutions to your study, program, or entire portfolio, for efficient and streamlined clinical development.
Biostatistics for Confident Decisions
We offer comprehensive biostatistics services, including consulting, study design development, interim analyses, and support for DSMC and IDMC meetings.
Our tailored solutions include programming statistical outputs such as SDTM, ADaM, and TLFs, ensuring precision and compliance.
With expertise in adaptive trial designs and advanced methods, we deliver validated, traceable, and reproducible analyses.
We seamlessly integrate with clinical data management services to support diverse therapeutic areas from protocol design to regulatory submission.
Case Study
Advancing Infectious Disease Research
We provided a full service for a Phase III vaccine study with 2000+ participants, including clinical trial data management and biostatistics.
With tight data timelines, fast data accrual and accurate management of large volumes of data were vital. We delivered:
- Customized data management
- Streamlined systems
- Risk‑based data review through centralized data monitoring
- On‑time data entry, query resolution, and database lock
- End‑to‑end biostatistics solutions, from CRF review to regulatory submission
Our tailored solutions ensured robust data management and analysis, advancing research for a challenging virus.
See our impact in actionFrequently asked questions
What clinical data management services do you provide?
We offer end‑to‑end clinical trial data services from protocol review to post‑study data processing, including design, testing, validation, and maintenance of 21 CFR Part 11 compliant electronic databases. Additionally, we provide stakeholder database administration training.
Our data management services also include risk‑based data management, review, and cleaning, centralized data monitoring aligned with the latest ICH E6 amendments, medical coding (MedDRA and WHO‑DD), and electronic patient‑reported outcomes (ePRO) integration.
We support external data reconciliation, integration with external randomization systems, database design and set‑up, and application development and EDC integration.
Do I have to use both clinical data management services and biostatistics services?
While we offer full‑service capabilities, we understand that every trial is unique. Our team works closely with you to provide what you need—data management, biostatistics, both, or something else. We’re here to collaborate and tailor our services to your goals, ensuring the best support for your study. Explore our Service Overview for more information.
How do you ensure compliance with global regulatory standards?
We monitor and adhere to global clinical trial data management standards, including ICH GCP and 21 CFR Part 11, ensuring data security, traceability, and accuracy.
Our validated systems and SOP‑led processes maintain compliance throughout the trial lifecycle, and our adherence to good documentation practices, disaster recovery, and backup services allow you to partner with us confidently.
What biostatistics services do you provide?
Our team works with you, using their expertise to deliver the best statistical approach and always adhering to CDISC (SDTM and ADaM) standards. Outputs include study design and protocol review, sample size and power calculations, randomization, and adaptive trial designs.
We provide biostatistics consulting services, feasibility analysis, statistical analysis plans, interim analyses, and Data Safety Monitoring Board (DSMB) support.
Our statistical analysis support extends to TLF production, clinical study report (CSR) input, narrative programming, patient profiles, and data conversion and integration.
Through deep regulatory expertise, we support submission strategy, planning, and analyses.
Do you provide documents in multiple languages?
Yes, we are a truly global provider of clinical data management services, providing documents in multiple languages. Our local experts ensure that all documents are accurate, culturally appropriate, and compliant with regional regulatory requirements.
Related Services
Study Design & Start‑Up
Partner with us to create custom, cost‑effective trial strategies that meet regulatory and sponsor requirements, regardless of project complexity.
Medical Writing
Get accurate, compliant documentation for every trial. We combine local expertise with a global perspective to deliver success from protocol development to regulatory submission.
Regulatory Consulting
Navigate the regulatory landscape with our global team, delivering tailored strategies and efficient clinical trial management from start‑up to safety reporting.
Endpoint Adjudication
Generate reliable, unbiased data and advance your study to the next milestone with support from global experts and efficient workflows tailored to every program.