Biomedical Research - What are the needs ?

It is strategic for a department that’s in charge of clinical operations to:

• Evaluate its needs and identify the stakes and risks for its system
• Guarantee the reliability of the results
• Ensure the traceability of documents, work, and results related to a research project
• Have a set of necessary data on hand, notably to facilitate the elaboration of the marketing authorization application file
• Offer guarantees and instill confidence in its partners, potential silent partners, and above all, the competent authorities 

The implementation of an efficient quality assurance system enables the satisfaction of everybody's needs: partners, companies, in-house players, etc., by answering many of the questions concerning its system; the following in particular:  

•  Are the department's activities described by a system of procedures which: 
  • Is regularly updated?
  • Respects the legal and regulatory measures?
  • Reflects company's practices in compliance with the state of the art commonly accepted in this field?
• Does the implemented documentation management system integrate:
  • Common rules for documentation management?
  • The traceability of document history (versions, approval circuits, submission to the authorities, etc.)?
  • The necessary measures in terms of document security: backup, protection against fire, etc.?  
• Is it possible to guarantee these procedures and the continuous improvement of the quality system, by, for example:
  • Conducting audits (self-inspections, internal audits, providers' audits, etc.)?
  • Evaluating client satisfaction?
  • Carrying out quality control?
• Does the currently implemented system enable all local or home-based collaborators to access the same set of quality documents (quality policy, quality manual, procedures, model of documents, etc.)? 
• Is the regulatory compliance of clinical research activities guaranteed?
  • Is the regulatory context and its changes well-known?
  • Are the recent regulatory developments all implemented in the documentation?
  • Are the needs in assistance on applicable regulations satisfied?
• Are the Collaborators, the Investigators, CRAs and Study Nurses trained on procedures, and on clinical research regulations?
• Are/were the computerized systems used in clinical research and managing the regulatory data the subject of a validation approach?
• Does the system use step-by-step risk management methodology to identify and minimize risks, i.e.:
  • Risk analysis?
  • Batch reviews?
  • Batch recall exercises?
  • Contingency plans?