Often, pharmaceutical companies avoid new laboratory testing methodologies prefering to stick to established procedures for drug development so as to avoid any potential regulatory ambiguity. This tendency to avoid new methodologies and regulatory scrutiny sometimes leads to slower progress, higher costs and lower probability of new product approvals. Furthermore, some pharmaceutical firms severely restrict academic research-based modifications to established laboratory testing procedures in drug development because of their concern over triggering costly adjustments to the established regulatory framework.
These structural and organizational inefficiencies have prompted the emergence and growth of contract research organizations (CRO's) in the past two decades. However, the growth of larger CRO's into global research and manufacturing companies has led these companies to exhibit the very inefficiencies they were created to eliminate. These inefficiencies, stemming from inflexible structures, complicated and long decision-making processes and a hesitance to become involved with the sponsors, prohibit meaningful, intensive and customized R&D projects.
Diteba's co-founder, Dr. Kapanadze, identified this weakness in the larger CRO's and aspired to create an environment where the brightest academic ideas could be efficiently integrated into a highly regulated drug development framework. This notion has become increasingly important in the last decade as the industry migrates away from blockbuster drugs that targeted the larger population toward tailored drugs that target smaller segments of the public. So a more flexible and R&D intensive CRO is clearly needed by both emerging and established pharmaceutical companies, which also takes into account recent advancements in genetic research.
In addition to incorporating the latest academic ideas in analytical research into drug development processes, Dr. Kapanadze also saw the need to embrace the latest advancements in electronic data capture in a laboratory setting. A comprehensive information infrastructure will guarantee compliance with the requirements that regulators apply towards ‘electronic signature' and ‘electronic audit trail' (e.g. e-lab infrastructure). Such infrastructure is vital for processing large volumes of laboratory testing data, while still preserving flexibility to incorporate changes into non-stop production processes.