The success of the clinical development organisation in an R&D company cannot be over emphasised. However, in the drive for fast enrollment and completion of studies, the quality built into the studies is often overlooked. Significant deviations and inappropriate enrollment can lead to erroneous conclusions from the study which can lead to a product failing to show efficacy or demonstrating an unacceptable safety profile. This can even result in failure to be approved that could cost the company millions of dollars.
Calcott Consulting has expertise in the clinical business processes and quality systems areas and can aid in assuring an appropriate level of quality for the stage of development of the product.
We can aid you in the following:
- Evaluation, design and remediation of clinical / pre-clinical systems and operations
- Audits of products, systems, files
- Preparation for and execution of inspection strategies
- Responding to regulatory bodies both in North America and the EU
- Development and tracking of remediation and assessing effectiveness
- Review and improvement in documentation systems
- Recommendation and implementation of e-tools to help streamline, unify and document business processes
- Integration of the quality function into the everyday operations of the clinical departments.
- Creation of a positive value added quality role
- Development and implementation of training and learning management systems
Contact us so that we can discuss your needs. We anticipate being able to deliver cost effective programs that meet your budget and timetable.