Supporting clinical development with expert services
Syngene’s experts provide comprehensive medical writing, medical monitoring, pharmacovigilance, and safety management services to support clinical development programs. Our highly experienced team of medical writers, clinical research physicians, clinical pharmacologists, and safety physicians provide high-quality deliverables in compliance with regulatory guidelines.
Capabilities
Medical writing
Syngene’s experienced medical writers use their scientific expertise to provide high-quality clinical study documents, including electronic common technical documents (eCTD), in compliance with the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and other regulatory requirements. Our medical writers collaborate with biostatisticians, programmers, and project team members from the protocol writing stage to final dossier preparation for submission. Every document undergoes a rigorous internal quality assurance process, enabling us to produce comprehensive documents that are ready for on-time submissions, in all stages of clinical development.
Our writers provide investigator brochures, clinical study synopsis, protocols, risk evaluation and mitigation strategies (REMS), informed consent forms, study assessment questionnaires, patient diaries, clinical study reports for phase I to IV, white papers, abstracts, posters, presentations and manuscripts, clinical overview and clinical summary as per regulatory requirements, medico marketing documents, and Data and Safety Monitoring Board (DSMB) manuals. Clients can access our services as part of a comprehensive clinical trial program or as a stand-alone service.
Medical monitoring
Syngene’s medical monitoring team includes experienced clinical research physicians who handle queries related to patient eligibility, patient safety, protocol deviations, and waivers. As primary contacts, the team handles medical queries from investigative sites, sponsors, and study team members and ensures quick resolution of medical issues. In consultation with sponsors, our medical monitors develop a study-specific medical monitoring plan and ensure that trials are conducted in compliance with study protocols and approved medical monitoring plans.
Our services include reviewing study documents such as protocols, investigational brochures, case report forms, and informed consent forms. We also handle protocol deviations, provide protocol waivers wherever acceptable, provide medical reviews of statistical and clinical reports, provide inputs during study feasibility assessments, and review adverse events (AEs) and lab reports.
Safety management
Syngene’s dedicated, experienced safety physicians provide valuable inputs towards the design of comprehensive study-specific safety management plans, ensuring that serious adverse events (SAEs) are accurately processed and reported as per regulatory guidelines. Our service portfolio includes coordinating and processing AE and SAEs case receipts, medically reviewing AEs and SAEs, preparing safety narratives, expediting reporting of SAEs to regulatory authorities, reconciliation of SAEs, and reconciliation of safety database with CRFs. We also have dedicated phone and fax lines to ensure 24/7 medical oversight of clinical studies.
Pharmacovigilance
Syngene offers comprehensive pharmacovigilance solutions during clinical development and post-approval phases. The team includes clinical pharmacologists with in-depth knowledge of diverse therapeutic areas and several years of experience in pharmacovigilance and safety management.
Our range of pharmacovigilance services includes the set-up and maintenance of global safety databases, as well as the collection, evaluation, analysis, and reporting of safety information from all sources, including spontaneous reports of adverse events of the marketed drugs. We also provide literature search in compliance with regulatory requirements, medical review of case reports, and online coding of adverse events using medical dictionaries such as Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization drug dictionary enhanced (DDE). We help in the preparation of safety narratives and in the preparation and submission of periodic safety update reports (PSUR) to regulatory authorities. We have dedicated 24/7 phone and fax lines to receive information on adverse events from clinical trial sites and post-marketing sources.
Infrastructure
Syngene’s clinical development services unit is equipped with robust IT solutions and expert resources that enable us to efficiently execute projects. Our clinical data management and biostatistics team uses various tools to improve the collection, consolidation, reporting, and analysis of clinical data. These include SAS PheedIt (21 CFR, Part 11) that is used for capturing and validating data for electronic data capture (EDC) and paper-based studies, SAS Analytics that helps us perform statistical analysis, Adobe PageMaker used for case report form (CRF) designing, and MedDRA® used for adverse event coding. We also use the WHO Drug Dictionary for medication coding and Phoenix® WinNonlin® to perform pharmacokinetic/pharmacodynamic (PK/PD) modeling and non-compartmental analysis.
