Your Trusted Partner For Clinical Research and Pharmacovigilance

MEDICAL WRITING

Drafting high quality Protocols, Informed Consent Forms (ICF), Investigators’ Brochure (IB), Clinical Study Reports (CSR), Clinical Evaluation Plans & Clinical Evaluation Report (CEP, CER) including literature search protocol, PICO analysis, Manuscripts for Publications.

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CLINEXEL SERVICES

  • Essential Documents for Clinical Trials (Protocol, IB, ICD, and CRF)
  • Clinical Study Reports
  • Literature Review & PICO Analysis
  • Clinical Evaluation Plans and Clinical Evaluation Reports
  • Performance Evaluation Plans and Performance Evaluation Reports
  • FAQs, Standard Response Letters, Publications, Fact Sheets

CLINEXEL EXPERTISE

  • Strong Knowledge of GCP & GVP
  • Professional, experienced staff (Ph.D., M.Pharm)
  • Medical Writers with Experience of Clinical Operations
  • Well versed with local and International Regulations
  • In house Physicians
  • Good connect with Key Opinion Leaders
  • Medical Experts (Full Time, In-House) provide Medical Inputs
  • Understanding of SOCs & Patient Management
  • Working with clients from the USA, Europe, India, and Asia
  • Working with pharmaceutics and device companies
  • Interactions with Notified Bodies for submissions under EU- MDR
  • Interactions and meetings with Competent Authorities during pre-IND, Scientific Advice, and EOP meetings

1. Regulatory Writing

  • Clinical Trial/ Study Documents:
  • Protocol
  • Investigators Brochure (IB)
  • Clinical Study Report
  • Request for Information (RFI) from Competent Authorities (CA)
  • Pre-IND Dossiers
  • BR /Health Hazard Assessments

2. Medical Device

  • Clinical Investigational Plans
  • ICD, IFU,IB
  • Clinical Evaluation Plans & Clinical Evaluation Report (CEP, CER)
  • Biological Evaluation Plans & Reports (BEP, BER)
  • Performance Evaluation Plans and Reports (PEP, PER)
  • Chemical Evaluation Reports

3. Scientific Publications

  • Manuscripts
  • Posters
  • Abstracts
  • Presentations
  • HTA Reports
  • Clinical Trial Reports

CLINEXEL is a professionally managed Company, a CRO is led by experts with experience in leadership positions in pharma and biotech companies.

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