Medical Writing

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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".

Key services in Medical Writing:
  • Clinical development plan
  • Design & development of clinical study protocols
  • Development of CRF, ICF & other documents
  • High quality data presentation & writing in accordance with global regulatory standards with sophisticated planning and execution
  • Experienced-based study protocol & ICF development
  • Preparation of FDA Summary Tables for ANDA Submissions
  • Custom format reports
  • CD-ROM copy and hard copy of reports and associated study data
  • Pharmacokinetics (PK) and Pharmacodynamic (PD) study designs
  • PK/PD modeling
  • Non-compartmental and compartmental, PK/PD, and population PK analyses