Protocol Development
& Medical Writing

Protocol Development & Medical Writing

Our expert team will assist you in design and development of most innovative protocols to get more information with a smaller study. Our team has more than 20+ years of experience in protocol development and medical writing.

Medical Writing Services:

  • High quality data presentation & writing in accordance with global regulatory standards with sophisticated planning and execution
  • Experienced team for study protocol & ICF development
  • Integrated study report writing in eCTD format with hyperlinking & bookmarking
  • Preparation of FDA Summary Tables for ANDA Submissions
  • Soft copy and hard copy of reports and associated study data
  • CS-BE preparation for TPD submissions
  • Preparation of abstracts, manuscripts, publications & poster presentations

Our Expertise:

  • Qualified, trained & experienced team of statisticians, SAS programmers, pharmacokineticists, and medical writers provide high quality data analysis & statistical report writing in accordance with regulatory standards.
  • Protocol preparation team holds strong experience in conducting clinical studies with medical or pharmacy background designed clinical studies.
  • Clinical physicians and consultants work closely with protocol preparation team to offer scientific inputs for study.
  • In-house medical writers and project management team involves in the study at every stage to bring about a comprehensive understanding of study and generate reports that are insightful and accurate.
  • Our skilled regulatory expertise ensures perfect report writing which minimizes any possible delay in regulatory approvals.
  • Team also understands our client’ need for fully integrated study reports in eCTD format with hyperlinking and bookmarking incorporating investigator and client requirements, while adhering to applicable regulatory guidelines and ICH-GCP norms. Our standard reports are prepared to conform to the requirements of the ICH E3 "Structure and Content of Clinical Study Reports".