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Pre-Clinical Research in the 21st Century

Before a medical device or pharmaceutical product is ready for market, it must be rigorously tested and documented in accordance with guidelines set by regulatory agencies and best practices in the field of study. Modern technology and knowledge makes this process more accessible and efficient, though at times navigating the twists and turns of regulation can be daunting.

Insuring the efficacy, safety, and biocompatibility of a new drug or device calls on a wide variety of experts in pre-clinical research, such as scientists, physicians, and surgeons, experienced administrators, compliance specialists, and marketing advisors. In the past, this combination of skill and knowledge was often difficult to find in one location, but the contract research organization (CRO) provides a unique and unifying solution. Assisting medical device and pharmaceutical product developers to realize their products from proof of concept to market penetration is the goal of CROs in the 21st century.

Pre-Clinical Research Focus
Safety testing, experimental surgery, research model development, and physician and sales force training are some examples of the focus of pre-clinical research. All these activities must operate within the framework of good laboratory practice, ethics (e.g., the proper care and treatment of animal models), and national and international governmental regulations. The endpoint to these procedures is the approval of a product and pre- and post-marketing research and implementation. From assistance with protocol preparation to post-market strategies, today’s CROs partner with sponsors to bring a product from concept to conclusion.

Protocol Preparation
In pre-clinical research, the sponsor of a study is responsible for preparing the protocol, which must be approved by the regulatory agencies involved before the trials can be started. This usually requires consultation with experts in both the area of study and the appropriate development and submission of documentation required for the applicable agency’s go-ahead.
GLP
Good laboratory practice is essential for insuring a properly run and approved pre-clinical trial. Depending on the type of drug or device being investigated, these practices may vary, but overall, they are intended to insure the validity and reliability of the study outcome.

Research Oversight
Modern pre-clinical research is replete with oversight and documentation. Studies are carried out under the eye of one or more federal, state, or international agencies, but are ultimately the responsibility of a signer overseer: the study director. This clinical research team member is the sole point of contact for the entire study, responsible for everything from initial preparation of the project plan to the finalized archiving of the pre-clinical trial’s results. This requires an individual well-versed in all aspects of pre-clinical research, often difficult to find within the sponsoring organization.

Regulatory Compliance
Guidelines for pre-clinical research, put forth by the FDA, USDA, DEA, and other regulatory agencies, are quite voluminous, and each year increase in number and specificity. Which guidelines are necessary depends on the type and scope of the pre-clinical study being conducted. For example, if a new medical device is being tested on live animal models, the USDA will also be involved, and a facility will recommend accreditation from the AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care).

Market Development and Post-Market Strategies
Once a new product has been tested and approved, the pre-clinical researcher must find ways to introduce it to those who need it most. This often involves identifying the purchasing decision-makers, training physicians and sales force members to understand and/or use the product to its best advantage, and formulating product information brochures and other PR materials to present the product’s benefits in the most appealing manner. Perhaps the most effective marketing tool available today is the Internet. A solid web presence, providing information to doctors and patients alike, as well as social networking and other digital media, are resources newly available to pre-clinical researchers. All these marketing techniques take a skilled designer, one who knows both the product and the appropriate marketing strategies inside and out.

Medical device and pharmaceutical product testing demands pre-clinical research of the highest procedural quality and detailed documentation, reporting, and archiving. In today’s computerized environment with almost instantaneous data analysis, evaluation, and storage, studies on healthcare products can be thorough and rapid. These 21st century technological advantages are coupled with the complex demands of procedural and regulatory compliance and marketing challenges. A state-of-the-art contract research organization—intimately familiar with the ins and outs of pre-clinical research—can provide answers to these challenges and prepare the way for a smooth transition from product proposal to placement.

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