Critical information path

After thorough review of clients’ non-clinical and clinical data as well as the scientific and medical knowledge base to date, IMD identifies key pieces of information necessary to move clinical development forward at the critical junctures. The critical information path for devices typically involve iterative human factors testing and validation in some cases leading to clinical evaluation or even demonstration of safety and effectiveness. For drugs including biologics the critical information path typically involves early establishment of adequate biomarkers and demonstration of a dose-response curve for efficacy and toxicity.
IMD produces Clinical Development Plans including essential components of trial designs to meet those needs and thus move development rapidly forward. Depending on the specific project plans often include combined Phase 1/2a or 2b/3a designs to compress overall development time. Trial designs include the latest technology including adaptive designs to make development efficient and the services include providing the necessary support to obtain agency agreement before execution. Plans are invariably developed with Regulatory experts as a part of the team to ensure plans move along clear regulatory paths leading to fast registration. As a part of Clinical Development Plans IMD can elaborate a Risk Evaluation and Mitigation System (REMS) for the health authorities.

Commercialization platform

Market adoption rather than registration ultimately defines success and to reflect that development plans are generated to yield data well suited to serve promotional needs in addition to registration purposes.

Adaptation to client resources

Development plans are adapted to the specific client’s various resource constraints whether they are financial or infrastructure related. For companies with limited resources, plans are designed to yield a steady stream of data to show progression towards registration. This maximizes clients’ negotiation position in talks with either potential partners or the financing community.