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Leveraging our Statistical expertise for better Clinical Study Design and Insights

Exciting innovations in data analysis and visualizations are paving the way for a better clinical experience. Our global clinical biostatistics and programming team offers a deep understanding of the science of disease areas and compounds and provides efficient upfront study design and comprehensive planning assistance.

We provide biostatistics and SAS programming services that help you derive meaningful insights from the data and be submission-ready.

We support the entire life-cycle from a statistical perspective, including study design and planning, interim and final analysis, and regulatory submissions.

Automated Insights

Multi-Dimensional Analysis

Faster Decision-making

Biostatistics Services

  • Pharmaceutical product development planning, Sample Size estimations, study design, and analysis, as well as supporting methodologies and statistical analysis plans
  • Clinical protocol development, Case report form, and Clinical study report review
  • Planning and implementing Study final and interim analysis
  • Publication support and Ad-hoc analysis
  • Support for all phases of clinical trials, from initial dose titration through post-approval services

SAS Programming Services

  • Validated Macros bring efficiency, cost savings, and accelerated timelines.
  • CDISC implementation (SDTM and ADaM, Define.xml, annotated CRF)
  • Experience with most major EDC platforms
  • Derived dataset production and validation
  • TLF production and validation
  • Regulatory submissions (Development of integrated ADaM datasets for ISS/ISE analyses, Define.XML)
  • Submission-ready datasets and programs

What Do Our Clients Say? 

Our experienced team, technical expertise, and sound procedures provide valuable biostatics services to ensure that our clients get the highest quality data.

Medical Writing

Our medical writers prepare clear, well-written documents designed to exceed expectations regarding both content and formatting. Our pharmaceutical product development service follows a highly collaborative approach, and it ensures our customer needs are met with the highest quality.

We offer a comprehensive suite of post-approval medical writing services, including:

  • Clinical Trial Protocol
  • Sample size reports
  • Clinical Study reports
  • Clinical Narratives (JNarratives)
  • Literature searches
  • Dossiers
  • Manuscripts
  • Abstracts

Clinical Data Management

  • We employ CDISC certified and CDASH compliant cost-efficient standard electronic data capture (EDC) solutions that help deliver high-quality data.
  • Our reporting tools offer comprehensive reports that help improve productivity during study conduct and database locks.
  • Our technology also supports ongoing data review and risk-based monitoring that ensures compliance of SOPs and enables reductions in research costs.
  • We can start-up studies within 4-8 weeks

eTMF Solutions

  • Our comprehensive reports help you track the accurate statuses of informed consents CVs Ethics committee approvals electronic case report forms financial disclosures and more which results in better productivity and compliance from study start to submission/archival.
  • Archiving allows any part or the entire eTMF repository to be securely exported to DVD or other media for independent offline review by independent auditors quality consultants or non-users.
  • Archives may be stored encrypted or for long term archiving stored unencrypted on DVD securely.
ETMF Solutions


  • Access to the sophisticated end-to-end electronic adjudication process
  • Expertise in managing adjudication in extensive outcome studies
  • We also work closely with the sites and CRAs to ensure endpoint packages are submitted in a timely fashion. You will have continued access to the status of endpoint reporting and adjudication.
  • We have successfully managed both efficacy and safety adjudication in phase 2 and phase 3 trials ranging from a few hundred patients to 10000 pts including paper and electronic adjudication.