Pre Clinical

Preclinical in-vitro and in-vivo studies are conducted in order to define the pharmacological and toxicological effects of investigational products (i.e. drug, biologic, advanced therapy medicinal product, medical device, combination product, diagnostic agent, etc.) prior to initiation of early-phase clinical trials and throughout the clinical development. There is no single uniform approach to design a preclinical program that suits all investigational products and studies must be tailored according to the type of investigational product, the proposed clinical trial under consideration and the respective guidelines or standards.

Preclinical strategy planning

A roadmap for advancing an investigational product from the laboratory phase to first-in-man studies is a fundamental tool. A well-planned preclinical strategy will reduce costs, improve efficiency and shorten timelines.

Gap analysis

Gap analysis aims to identify any additional studies required to support the pharmacological and toxicological development of the investigational product after a thorough review of all available information. The gap analysis can minimize unnecessary studies taking into account current regulatory requirements.

In-vitro & in-vivo preclinical study design

Consideration must be given to selection of the appropriate animal model, route of administration, treatment frequency and duration, product manufacturing and stability, as well as the intended clinical use, in order to provide the most accurate prediction of the potential pharmacological effects or toxicity in humans as required by the regulatory authorities.

Draft/review preclinical study protocols and reports

The study protocols and reports are the most important output from the study. A well-written study protocol will promote proper performance of the study. A study report is an essential part of the regulatory submission and must be written clearly leaving no doubt concerning what was done in the study and the outcome.

Performance of systematic literature review & interaction with the regulatory authorities

Literature review to obtain scientific support and justification for the proposed preclinical program towards discussion with the regulatory authorities.

Provide assistance for preclinical CRO selection

Usually the main parameters used for selection of preclinical CRO are GLP accreditation, short timeline and competitive price. However, one should be aware that other important parameters such as quality of reporting, communication and scientific support must be considered as well. Compliance with GLP reflects only the standard of working practices and facilities and not on the quality of the report or the scientific data interpretation, which impact later acceptance by the regulator.

Pre-Clinical CRO audit

Prior to placing work with the selected CRO, it is important to perform an audit (i.e. visit the facility, review the standard operating procedures, quality system or former regulatory inspections, meet the staff intended to perform the study, etc.) in order to verify that the CRO meets the required criteria. Oversight of the preclinical study performance at the selected CRO is also advised.