Services

We provide healthcare research solutions support to clients globally in following areas.

➤  Research Consultation

      •   Providing expertise for execution of medical, scientific and other healthcare research projects
      •   Consultation on designing, setting and conduct of complex epidemiological studies, clinical studies ,preclinical studies and other healthcare           research activities
      •   Planning research studies according to protocol, relevant regulations and SOP’s
      •   Evaluation and assessment of research methodologies, risk estimation strategies, use of software, statistical methods and data analysis plan
      •   Designing of research proposals, grant applications and risk management and mitigation plans
      •   Designing questionnaires and moderator guide to ensure proper follow up of research activities, data capture, data analysis, manuscript           preparation and publication planning

➤  Regulatory Writing

      Development and execution of
      •   Investigational product development plans
      •   INDA,NDA,BLA,MAA,ANDA,IDA,PME,CTA,IMPD,eCTD,DMF
      •   Clinical study protocols
      •   Clinical study reports
      •   Common technical documents
      •   Investigator’s brochures
      •   Patient safety narratives
      •   Periodic safety update reports
      •   Patient safety update reports
      •   Integrated summaries of safety (ISSs)
      •   Integrated summaries of efficacy (ISEs)

➤  Scientific Communication

      Development and execution of
      •   Study organization and implementation strategy
      •   Scientific evaluation
      •   Abstracts
      •   Manuscripts
      •   Literature reviews
      •   Clinical case reports
      •   Publication planning
      •   Editorial support
      •   Project management