Third party vendors – laboratories (TPVLs) are significant partners in clinical trials since laboratory results play a vital role in evaluating new drugs determining the safety and efficacy selleck chemicals Axitinib of the drug in patients. Following factors influence preference of TPVL for clinical trials: Advanced technology Well-trained and skilled resources Logistical support for collection and transport of biological samples On-time processing of samples Online delivery of results Rapid trouble shooting In-house mechanism for quality assurance and compliance Good laboratory practices (GLP) certification/accreditation Sponsors (pharmaceutical companies accountable for the clinical trial) can leverage the services of vendors to benefit both parties. However, managing third party vendors can be challenging.
This article explores the management and relationship between customers and TPVL within the data management process. TPVL TPVL manage pharmacokinetic/pharmacodynamic, serology, stool and blood analysis data during the clinical trials. They provide different forms of services to their customers, based largely upon on the specific therapeutic area. For example, serology data is important for vaccine trials. TPVL data processing involves many steps [Figure 1]. All the process steps are very important in TPVL data because one step will affect all the other steps through a sequential or cascading effect. Figure 1 Third party laboratory data process TPVL SELECTION Selection of a TPVL is a cumbersome process and risks are very high because it involves biological samples for analysis.
TPVL are selected based on the specific requirements GSK-3 of the clinical trial and sponsor expectation.[5,6] ARQ197 cost The key points that need to be considered while selecting third party vendor are: Evaluate the risk of utilizing or not utilizing vendor Evaluate vendors prior to contracting Define expectations, deliverables and responsibilities Confidentiality agreement Identify other possible vendors as part of a backup plan TPVL. TPVL operates in different geographical locations and hence standard laboratory practices should be maintained in both central and local laboratories. Some key factors for selection of laboratory vendors for clinical trials include [Figure 2]: Figure 2 Selection criteria’s for third party vendors for laboratories The testing procedures should follow GLP throughout the operations in the laboratory and they should comply with national and international regulatory standards Laboratory accreditations provide a clear picture of laboratory proficiency in techniques and staff Laboratory personnel should be well-trained in standard operating procedures, in the operating systems and techniques.