Figure 1. Schematic representations of (a) traditional sponsor-CRO interaction and (b) of a clinical development partnership.

A new strategy A new alternative strategy, which combines the best of the latter two options, has been used successfully over the past three years and may represent a more attractive option to many biopharmaceutical companies. This solution requires a very close, transparent, and flexible partnership with a provider of full clinical development services, with adequate measures and systems to maintain sponsor control and awareness, high project focus by both parties, and very rapid response times owing to constant and open communication. This type of partnership also offers significant opportunities for a transfer of know-how between the partners. This can accelerate and improve the development process for emerging and growing biopharmaceutical companies.

Biopharmaceutical companies are incredibly successful at identifying drug candidates. Technological improvements, such as high-throughput screening techniques and the rise of proteomics and genomics, have made this possible. At the same time, biopharmaceutical companies have realized the need to move from technology platforms to product development to become the future players of the new biopharmaceutical arena. Now, the challenge is to choose the best strategy to take their highest risk ever-bringing drug candidates through clinical development.

Internal clinical development A few companies choose to manage the clinical development of their product by hiring their own staff, often complementing them with contracted individual resources. The main motivations usually are to keep close control of the clinical development process and an expectation of lower development costs. While this certainly allows control and management of the clinical trials, these companies face high initial and running fixed costs, which will rapidly escalate as development progresses. Clinical development requires a variety of expertise and processes to conduct a large number of highly specialized, different activities. No company can assemble such expertise and develop an entire set of processes that adhere to the ever-increasing standards of international and national research in just a few months. Therefore, many of these companies actually lose time (the cost of which is usually not accounted for) and struggle to conduct their programs at required quality levels. Secondly, these considerations are complicated by the international nature of clinical development, which, to achieve efficiency, should be conducted in specific countries based on such factors as product indication, clinical development phase, regulatory frame, and local medical practices. By significantly increasing their fixed cost basis, these companies limit their ability to react in the event of product failure. Thus, the clinical development costs of managing clinical development internally may actually end up being much higher than when choosing an outsourcing strategy, and significant amounts of time may be lost.

Clinical outsourcing Most biopharmaceutical companies choose to outsource their clinical development program to one or several of the many available CROs. Properly selected clinical CROs can indeed assemble experienced clinical research staff in diverse locations and provide high-quality processes to conduct all clinical research functions in compliance with regulatory requirements. Three critical factors for CRO selection are capability (available resources, experience in the therapeutic area, geographical location, and nature of services), compatibility (of corporate cultures), and cost.¹

However, the performance of CROs has come into question due to lack of clarity on pricing and control.² Additional concerns have been expressed by emerging biopharmaceutical companies about the level of attention and commitment received by their proportionally small projects in the midst of large CRO preferred-provider contracts with large pharmaceutical companies. As a result, many of those companies regularly switch providers of clinical services and end up with significant time lost and high costs to restart new collaborations for each study, study databases in noncompatible systems or formats and in various locations, and a generally negative impression of CROs.

Measuring CRO performance has been the subject of several reviews, and various metrics have been proposed.³ While metrics are indeed essential in CRO performance assessment, various intangible elements of the sponsor-CRO interaction remain critical to final sponsor satisfaction with the CRO. Some of these intangibles are flexibility, commitment, transparency, and response time. Improvements in these areas have become essential for the CRO industry and are emerging with the new generation of CROs, which support these key operating values with new technological solutions to provide instant access to high-quality data and study progress information.⁴

The insufficient level of information exchange between CROs and sponsors (mostly perceived or interpreted as lack of transparency) is a key element in clinical project delays. A very good knowledge of the process and of the progress of the clinical project by the sponsor ensures fast reactions and decisions, facilitates sponsor-CRO interactions, and ensures a project-driven approach that may result in saving months on the product's time to market. It is common knowledge that one month of delay in the time it takes for a product to reach the market results in missed product sales of $25 million for a product that would achieve peak sales of $300 million per year. The need for transparency is also absolutely essential to biopharmaceutical companies with limited product portfolios due to the companies' high dependency on the product.

Historically, we have seen over and over again that the issues that arise on internally-run projects also arise on outsourced projects. These situations very rapidly develop into scenarios of placing blame and pointing fingers, and people lose focus from the task at hand-moving the project along.

If there is a spirit of close partnership with shared project teams and common goals, however, analysis of project issues is done as a joint team, resulting in prompt actions, swift resolutions, and continued focus on the best interests of the project.

From working together through the learning curve of the sponsor-service provider relationship, a sense of partnership will develop, enhancing the feeling of a shared ultimate goal-successful product development.