Thursday, January 22, 2009

Quality Control {QC} of NDA/eCTD Submission Documents

From the desk of Dante.

  • The submission is complete.
  • The regulatory forms filled out.
  • The checklist is being filled in.
  • Timelines are met.
  • While reviewing some late data, you find an error.
  • Panic begins.
  • QC was never performed or even part of the submission plan.
  • What happens next is a horror.

  • QC of submission data and documents is important.
  • QC can vary significantly from company to company.
  • QC and the process and planning should begin at the very beginning with the programming of data, the writing of clinical study reports and as the eCTD pyramid builds into integrated databases, clinical and nonclinical summaries and high level overviews.

It is a daunting task, but a solid QC plan is a must to ensure low error rates and data accuracy and consistency.

Friday, January 16, 2009

GIDB - Global Integrated DataBase

From the desk of Dante.

Early in the planning stage of your GIDB and SAP {Statistical Analysis Plan} remember for clinical safety data, FDA is asking pharmaceutical companies to integrate their data in this manner:

  • Phase 2-3 database - dose-finding and pivotal studies
  • Phase 1 database - "some pooling across all studies".

Also, an ISS {Integrated Safety Summary} is often required, even though the eCTD submission backbone assigns safety data to Module 2.7.4, the Clinical Summary of Safety.

I strongly advise an open communication and negotiation with FDA concerning data presentation and integration in your submission, however, in my experience, the above rule almost always applies with global safety data.

Friday, January 9, 2009

21Part CFR FDA Guidelines "are" Critical Path Tools

From the Desk of Dante.

How important are "Critical Path Tools", commonly know as FDA Guidelines? Extremely important. Yes, you are correct, guidelines are not "requirements", however, in many cases, will have greater impact on the overall success of the drug's development phase and ultimate chance for approval.

FDA Critical Path Tools {Guidelines}:
  • are science-based documents that eliminate uncertainly and ensure quality and integrity
  • will provide valid evidence of product safety and efficacy
  • will provide manufacturing quality and consistency.

I encourage all stakeholders to:

  • collaborate
  • improve
  • negotiate
  • and communicate...with FDA on guidelines, and of course, follow the requirements.

Start today!

Tuesday, January 6, 2009

When do you think Quality Control begins...

...Patient Case Report Form {CRF}?
...Investigator's Brochure {IB}?
...Study Database Lock?
...Patient Profiles?
...Expedited Safety Reports?
...CRA Monitoring Reports?
...SAS Data Tables, Listings, Graphs and Figures?
...Statistical Analysis Plan {SAP}?
...General Investigational Plan {GIP}?
...Investigational New Drug Application {INDa}?
...In-license of a potential new drug or company acquisition?