Investigational Medicinal Product (IMP) Management in the Clinical Phase

Eliminate Potential Roadblocks in the Progression of Clinical Trials

During the clinical development phase, a variety of regulatory requirements are applicable for Investigational Medicinal Products (IMPs) or placebos. The requirements are not only limited to packaging, labeling, and release, but also cover a variety of additional areas.

ProPharma Group consultants are experts in all requirements applicable to your specific IMP(s) and will assist you to overcome possible hurdles, as well as help you set efficient and attainable timelines. Moreover, our team stays current on industry trends, and is familiar with what health authorities are looking for in relation to new drug development process and technologies.

For instance, within the last few decades, conduct of clinical trials has become highly digitalized with technologies (e.g. IVRS, ePROs) capable of streamlining trial processes, increasing trial quality, efficiency & flexibility, reducing costs, and improving patient compliance. However, the quality and integrity of a trial stands or falls by the reliability of these systems – often provided by third parties – and the interfaces between them. Health authorities are aware of challenges regarding this digitalization of clinical trials and as a result, data integrity has their attention.

With our strong experience in GCP and quality assurance of computerized systems, ProPharma Group has the knowledge and experience to help navigate through these kinds of regulatory challenges.