Our offerings include

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Consulting

  • Risk Based Monitoring: SOP development, Implementation Strategy, Change Management
  • CDM: SOPs, audits, CRF designing, development/review of key plans
  • Medical Writing: Providing review for Protocols, CSRs, IBs, publications, reviews, lay summaries
  • Techno-commercial support, providing subject matter expertise for platform development, business development
  • BoT model for establishing operations in India
  • GTM and pricing strategy
  • e-consenting solutions
  • Industry landscape analysis, buy/sell decisions

 

Training

  • CDISC Training - 1 day workshop
  • RBM Training - Niche, customized workshops, 2 - 4 day training programs on RBM
  • Medical Writing - 1- 2 day workshop
  • GCP Training - 1 day workshop

Services

  • SDTM, ADaM Data sets: Programming of data sets, review of data sets for submission to the FDA. Both India and US based resources available
  • Medical Writing: We can offer both US and Indian experts to provide medical writing services. The range of services offered include CSR, protocols, IBs, ICF, PIS, clinical overviews, summaries of safety and efficacy, IND/IMPD documents and ethnic sensitivity assessment documents, manuscripts, posters, slide decks,review articles, lay summaries.as well as registration of clinical trials on clinicaltrials.gov. The panel includes MDs, PhDs with significant expertise in medical writing.
  • Biostats: We have on our panel an experienced biostatistician with close to 2 decades of experience. Has worked on over 50 studies for performing sample size calculations, SAP development, performing statistical analysis, developing statistical reports, and around 20 - 30 studies for providing inputs to protocols and performing randomization. Experience across diverse therapeutic areas, including oncology, dermat, gastro, neuro, HIV, opthalmology etc. as well as BA/BE studies.
  • SEO and content development for websites of pharma companies.

Placements

  • Leadership Roles and Operational Roles
  • CRAs
  • SAS programmers
  • Medical Writers
  • Data Managers
  • BD professionals
  • Central Monitors
  • Project Managers
  • PV associates