Document Types
Protocol & Protocol Amendments
- Conceptualization of protocol
- Well versed with SPIRIT Guidelines
- Experience on working on varied protocol templates across different clients
- Know-how and utilization of the Common Protocol Template – TransCelerate
Informed Consent Documents
- ICF, Subjection information sheet, Assent and Audio-visual Consents
- Ability to translate English ICD to regional languages
Clinical Study Report (CSR)
- ICH E3 compliant Full, Abbreviated, and Synoptic CSRs
- Sound Statistical understanding and interpretation for drafting results
- Capable of authoring pharmacokinetic (PK) and pharmacodynamic (PD) results
- Unique ‘Review Panel’ by medically qualified MW for CSR authoring
- Lead Review Meetings/Comments Resolution meetings
Investigator’s Brochure
- Authoring of Initial IB, IB Updates and IB Addendums
- Alignment with DSURs with respect to CTFG guidelines
eCTD Modules
Well versed with QC of CO, SCS, SCE, SCP, ISS, ISE, Response Documents, Briefing Books, 120-day safety updates.
Authoring of Clinical Overview and Briefing Documents.
Dedicated Quality Control Group
Well versed with QC of CO, SCS, SCE, SCP, ISS, ISE, Response Documents, Briefing Books, 120-day safety updates.
Authoring of Clinical Overview and Briefing Documents.
U.S. trained Medical Writers.
Sole partner for Quality Control for TAs like Immunology and Virology for a sponsor.
Dedicated Quality Control Group
Well versed with QC of CO, SCS, SCE, SCP, ISS, ISE, Response Documents, Briefing Books, 120-day safety updates.
Authoring of Clinical Overview and Briefing Documents.
U.S. trained Medical Writers.
Sole partner for Quality Control for TAs like Immunology and Virology for a sponsor.
Publishing
Collation of Appendices and relevant documents.
Therapeutic Areas experience across Phases 1 to 4
