What Everyone Ought to know About Central Laboratory Services

Posted by arun on June 16th, 2014

Selection of an appropriate central laboratory is more important, as it will have a say about the veracity of the results of the clinical trials. The central laboratory should provide the following services and supports.

 Nowadays, the clinical research is assuming more increasing scales and complexities of clinical lab services. Therefore, Central Lab Services should address the principles of value and insight besides being geographically dispersed, so as to cope up with such complexities. Therefore, for efficient management of clinical travels, the responsibility of the central laboratories in developing drug products becomes increasing important and critical. The central laboratories should provide quality data at a faster pace with flexibility and efficiency so that the projects are completed as per the time schedules and as per the budget. Such punctual deliveries by the Central Laboratory Services are very important for the achievement of the goals of their clients.

 Central Laboratory should adhere to strict quality assurances and other applicable guidelines. It should have and maintain many national laboratory accreditations and certifications, in different areas, since it will have many laboratories spread over the globe. The laboratory services would include external laboratory management, project management, scientific consultations, Investigator support kit, flawless data management, high volume safety tests, biomarker testing, quality assurance, bio-banking and digital pathology.

 A central laboratory will be considered and preferred if it has to its credit the expertise of having conducted millions of laboratory tests for a large number of protocols at the international level, working with considerable number of investigator sites logistically. The drug trials should be supported by a wide array of laboratory services and devoted assay development services. Besides the laboratory testing, they will render other associated services which are critical to the efficient execution of the study. Such other central laboratory services may include consulting, clinical trial services, product marketing/ sales, Real world and late (RWLP) phase strategy/ research, digital patient services, education, including continuing medical education and medical liaison, anatomic pathology services

It should have enough/ extensive experience and deep scientific expertise/ exposure and capabilities for testing and other areas built over consistent track records of successful achievements.

 It will have one web based global database, without the trouble of integrating or harmonizing data from various systems. It will have many centers, situated across the world, access to the study sites globally. The results of the services should be consistent and also comparable from study to study and region to region. Experienced scientists/ skilled project managers will have to be assigned to coordinate with the client teams and to take care of their specific requirements. To accomplish all the expectations, the central labs should have state of the art instruments, devices, equipments. The labs should offer central lab services in such a way to provide higher quality at lower costs.