Often, pharmaceutical companies avoid new 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 and higher costs. Furthermore, some pharmaceutical firms severely restrict academic research-based modifications to established 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) in the past two decades. However, the growth of larger CROs 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.
Dr. Kapanadze identified this weakness in the larger CROs and aspired to create an environment where the brightest academic ideas could be efficiently integrated into highly regulated drug development frameworks. 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 into drug development processes, Dr. Kapanadze also saw the need to embrace the latest advancements in electronic data capture. 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 data, while still preserving flexibility to incorporate changes into non-stop production processes.
Diteba Research Laboratories Inc. was founded in 2003 to deliver personalized, R&D intensive solutions to clients in the pharmaceutical, biotechnology and natural products industries. The team at Diteba Research Laboratories Inc. comprises professionals averaging more than 10 years experience in analytical and bioanalytical chemistry. Our team has worked with the world's largest CROs and pharmaceutical companies and also brings a wealth of knowledge from academia. Our knowledge and experience allows us to conduct your studies in a timely and efficient manner.
Diteba Research Laboratories Inc. occupies 9,000 square feet of fully network-equipped, state-of-the-art laboratory and office space, including a stability storage room with temperature/humidity chambers covering entire ICH recommended range of storage.
Diteba Research Laboratories Inc. is a private corporation located in a newly built facility in Toronto (Mississauga), Ontario, just minutes away from Toronto International Airport.