Monday, January 4, 2010

Clinical Documentation - Medical Writers and QC (Quality Control)

A clinical development program/CTD clinical submission for drug, biologic, device, vaccine, gene-product, stem cell, monoclonal and otherwise, require a range of documentation, regulatory, non-regulatory, clinical, non-clinical, major and minor, all require process and procedural adherence, all require QC (quality control) of data, all require QA (quality assurance) of guidance completeness and compliance. All require tracking and monitoring. All require project management for realistic timelines, resource and capacity. All require dedicated medical writers.

The range of documents required for a clinical development program which by normal progression populates your CTD (Common Technical Document) Clinical Submission includes but is not limited to the following -

  • CSP (Clinical Study Protocol)
  • CSR (Clinical Study Report)
  • CTR (Clinical Trial Report)
  • CTD Module Summaries
  • Informed Consent Form
  • Narratives
  • Subject Patient Profiles
  • PIP (Pediatric Investigative Plan)
  • RMP (Risk Management Plan)
  • Manuscripts
  • SmPC (Summary of Product Characteristics)
  • USPI (United States Package Insert)
  • Posters
  • PSUR (Periodic Safety Update Report)
  • ASR (Annual Safety Report)
  • IB Investigator Brochure
  • IMPD (EMEA Product Dossier)
  • CTA (Clinical Trial Application)
  • IND (Investigational New Drug Application)
  • NDA (New Drug Application)
  • GIP (General Investigative Plan).

It is imperative to have your clinical development team and your clinical submission team work together at the beginning of your clinical development program (CDP) through to filing to ensure efficiency and quality.

It is imperative that expert medical writers and QC work together in the early document development stage, preparing thoughts and clear structured statements. Thoughts and statements that are real and can be supported by data.

By organizing the medical writers and QC teams early in the development of your documentation, it will streamline the later stages of the CTD and streamline all documentation.

Using the same teams, medical writers and QC and keeping those teams together until the filing of the dossier will ensure overall efficiency, consistency and accuracy.

When does QC begin? Which documents should be QC? At the beginning of the clinical program and all documentation, respectively.

What is the benefit of having early medical writing and QC teams? - The benefit and result can be easily measured in metrics pertaining to ROI (return on investment) -

  • # of document revisions are reduced
  • # of QC cycles are reduced
  • # of document drafts are reduced
  • # of team reviews are reduced
  • time to filing is reduced
  • costs of the CDP and CTD are reduced
  • impact on employee manpower is reduced
  • impact on pharma organization is reduced
  • CRO outsourcing, timelines, efforts, materials, consultants, tasks are reduced.

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