Putting Science to Work

Medical Writing and Medical Monitoring Services

Medical Writing

Syngene has a team of experienced medical writers with scientific expertise to provide high quality clinical study documents (including eCTDs) compliant with ICH guidelines and regulatory requirements. From protocol writing to the final report preparation, our medical writers collaborate with biostatisticians and project team members to produce comprehensive, submission-ready documents for all stages of clinical development. Every document goes through a rigorous internal quality assurance process ensuring high quality deliverables on time. We provide medical writing services as part of the comprehensive clinical trial program or as a stand-alone service.

Our medical writers help you in the preparation of the following documents:

  • Investigator brochure 
  • Clinical study protocols 
  • Informed consent forms 
  • Study assessment questionnaires 
  • Patient diaries 
  • Clinical study reports – phase I to IV 
  • Abstracts and manuscripts 
  • Clinical overview and clinical summary (sections 2.5 and 2.7 of CTD) 
  • DSMB manuals 
Medical Monitoring

Syngene's medical monitoring team comprises experienced clinical research physicians to handle queries related to patient eligibility, patient safety, protocol deviations and waivers. They are the primary contact to handle medical queries from investigative sites, sponsors and study team members to ensure quick resolution of medical issues. The medical monitors, in consultation with sponsors, develop a study-specific medical monitoring plan and ensure that the trials are conducted in compliance with the study protocol and approved medical monitoring plan.

Our medical monitoring services include:

  • Reviewing study documents – protocol, investigational brochure, case report forms and informed consent forms
  • Handling protocol deviations
  • Providing protocol waivers, wherever acceptable
  • Medical review of statistical and clinical reports
  • Providing inputs during study feasibility assessments
  • Reviewing adverse events (AEs) and lab reports
Safety Management

Through a team of dedicated and experienced safety physicians, we provide- highly credible inputs for designing comprehensive study-specific safety management plans to ensure that Serious Adverse Events (SAEs) are reported and processed accurately as per the regulatory guidelines. Syngene has set up dedicated phone and fax lines to ensure 24/7 medical oversight of clinical studies.

The safety management service portfolio includes:

  • Coordination and processing of AE and SAE case receipts 
  • Medical review of AEs and SAEs 
  • Verification of AE coding 
  • Preparation of safety narratives 
  • Expediting safety reporting 
  • Reconciliation of SAEs 
  • Reconciliation of safety database with CRFs 
Pharmacovigilance

Syngene offers comprehensive pharmacovigilance solutions during both clinical development and post-approval phases. The pharmacovigilance team comprises clinical pharmacologists with in-depth knowledge in diverse therapeutic areas and several years of pharmacovigilance and safety management experience. Syngene has set up dedicated 24/7 phone and fax lines to receive information on adverse events from clinical trial sites and post-marketing sources.

Our range of pharmacovigilance services include:

  • Set up and maintenance of global safety database 
  • Collection, evaluation, analysis and reporting of safety information from all sources including spontaneous reports of adverse events of the marketed drugs 
  • Literature search in compliance with regulatory requirements 
  • Medical review of case reports 
  • Online coding (MedDRA, WHO DDE) of adverse events 
  • Preparation of safety narratives 
  • Preparation and submission of Periodic Safety Update Reports (PSURs) to regulatory authorities 

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