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ROI CalculatorIn the field of clinical research, the term "investigational product (IP)" refers to any drug or biologic, medical device, vaccine, diagnostic tool, or placebo that is being tested or utilized in a clinical trial. This concept touches upon investigational drugs that may include products that are not already authorized for sale on the market as well as those that have already received a authorization for use but are being studied for an off-label application or as new formulations. When the IP is regarded as a medicinal product, it may also be called an investigational medicinal product (IMP).
The procedure of managing investigational products in clinical trials is characterized by multiple levels of oversight. This procedure resembles such stages as design/development, manufacture, packaging, labeling, shipping, and distribution to the clinical trial sites. Sponsors are responsible for ensuring compliance with regulatory requirements along the entire chain of custody of the drug, which may vary from one step to another.
The investigational product goes through several stages and entities before reaching the final consumer. However, the sponsor of the clinical trial is responsible entirely for the investigational product's management. The sponsor has to make sure there are sufficient quality control processes in place so that the product is manufactured and transported appropriately.
Investigational product management corresponds to a well-defined sequence of processes where the quality and integrity of the product must be ensured as part of the system thanks to statutory rules.
For the drug to be produced properly, the drug formulation, synthesis, and packaging processes must be followed according to the relevant good manufacturing practices (cGMP) regulations. Since the way drugs are manufactured is quite different from the clinical trials process, many sponsors choose to involve other companies in conducting the drug manufacturing. A contract manufacturing organization (CMO) or contract development and manufacturing organization (CDMO) would be the typical choice, although some CROs also offer these pre-trial services.
The distribution may entail particular specifications, like requiring a cold storage solution or speedy delivery to get the medicine to the patients prior to expiry. Detailed and clear instructions for the transport and storage of the investigational products should be formulated. In most cases distributors will have to follow particular regulations, meaning that they may have to operate only special lines with background knowledge in transporting clinical drugs. Any transportation of the investigational medicine must be noted to ensure effective control of compliance.
It is essential to provide detailed instructions for the trial sites and staff and patients concerning the dosage, administration, handling, storage and disposal of the investigational drug.
The terminologies used in clinical studies such as investigational product, investigational medicinal product, study medicine and experimental medicine all imply one and the same thing, the substance that is being tested for its effects on humans.
According to the definition of study medicine, the substance that is being studied is either yet to be approved for commercialization and use, or is being studied for a purpose which is different from the one for which it has already been approved. Nevertheless, sponsors of clinical studies are required to follow certain rules to guarantee the quality, safety, and effectiveness of the study substance.
