Medical Writing

ClinSync also provides standalone services for protocol, ICDs preparation, and Reports (Clinical and bioanalytical) with various molecules. As of now they successfully completed more than 1000+ study protocols and Reports with different regulatory submissions. 

We are specialized in

A. Protocol & Protocol Amendments

  • Conceptualization of protocol for both BA/BE and Clinical Trial studies.
  • Well-versed with SPIRIT Guidelines.
  • Experience in working on varied protocol templates across different clients.

B. Informed Consent Documents

  • ICF, Subjection information sheet, Assent and Audio-visual Consents.
  • Ability to translate English ICD to regional languages.

C. 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.

D. Investigator’s Brochure

  • Authoring of Initial IB, IB Updates, and IB Addendums.
  • Alignment with DSURs with respect to CTFG guidelines.

E. eCTD Modules

  • Well-versed with QC of CO, SCS, SCE, SCP, ISS, ISE, Response Documents, Briefing Books, and 120-day safety updates.