We specialize in study implementation across all the leading EDC platforms. With our vast experience in a variety of EDC platforms, we are well positioned to guide you on the most suitable platform fitting your needs, based on phase of the study, type of study, therapeutic area, features, helpdesk support and licensing cost.

Once the protocol is approved and you choose your preferred platform, we accelerate the study setup process to help you quickly achieve the First Patient In / Go Live milestone, using our exhaustive, reusable CRF libraries and accelerators.

We offer comprehensive Clinical Data Management services for a variety of EDC / paper-based clinical studies. By integrating our domain, technology and regulatory expertise, we help you achieve clean study data at an optimised cost without increasing study risks.

We help global BioPharma companies successfully and confidently file their study data for FDA / Regulatory submissions, by putting patient safety at the heart of our process and wrapping it up with our therapeutic expertise.

We convert and standardize legacy research data or on-going study data to the CDISC standards including SEND, SDTM, ADaM and sponsor specific standards. Harnessing our CDISC expertise along with our domain knowledge and regulatory requirements, we have helped global BioPharmas shorten the time taken to create "submission ready" datasets.

Our CDISC consultants provide all the required inputs to our sponsors, right from CRF design as per CDASH standards to creating submission and analysis datasets using SDTM and ADaM standards.

We provide biostatistics services for conducting all activities associated with data summarization, statistical analyses and reporting of the study. Our team has extensive experience in designing, analyzing and reporting clinical studies across a broad range of therapeutic areas, supported by robust processes and a global infrastructure.

Our biostatistics services include providing statistical inputs to clinical protocol and CRF design, sample size determination, creating statistical analysis plans, generating tables, listings and graphs, interpreting and reporting the results. Our biostatistics team provides consulting support during Meta-Analysis and integration of safety and efficacy analysis.