Medical Writing

Our dedicated medical writing team is pivotal to the clinical research process, crafting scientifically rigorous and regulatory-compliant documents that align with sponsor objectives and international guidelines. We work closely with ethics committees to facilitate smooth and timely approvals, ensuring all documentation upholds ethical standards and regulatory expectations.

Medical Writing Services Include:

  • Protocol Development

    • Creation of detailed, scientifically sound protocols aligned with regulatory requirements, standard clinical practice, and sponsor needs.

  • Protocol Amendments

    • Timely updates reflecting study modifications, new safety data, or regulatory feedback.

  • Informed Consent Forms (ICFs)

    • Development of clear, ethical, and patient-friendly consent forms to ensure informed participation.

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  • Case Report Form (CRF) Preparation

    • Design and documentation of CRFs to ensure accurate and consistent capture of all required data points.

  • Clinical Study Reports (CSRs)

    • Comprehensive and transparent reporting of study outcomes, prepared according to ICH E3 guidelines.

  • Bioanalytical Sample Analysis Reports

    • Detailed documentation supporting pharmacokinetic and bioequivalence study results.

  • Method Validation Reports

    • Reports confirming analytical methods meet regulatory standards for accuracy, precision, and reliability.

  • Biostatistical Reports

    • Statistical analysis and interpretation of clinical data supporting study conclusions and regulatory submissions.

Medical Services

Medical Oversight:
  • Training of study teams and site personnel
  • Coordination and representation at SEC meetings with CDSCO
  • On-site and central monitoring to identify risks and implement mitigation strategies
Medical Writing Support:
  • Feasibility survey reports and disease demographic data (India and global territories)
  • Protocols and clinical study reports
  • Informed consent documents and patient diaries
  • Case report forms and patient support aids

We combine scientific expertise with clear communication to ensure the highest quality documentation and clinical support throughout your study lifecycle.