Laboratories should have access to couriers or overnight deliveries for receiving the biological samples. They should process the samples on time irrespective of the day and time and results should be available on time unless limitations of the test. TPVL SETUP AND MANAGEMENT TPVL management is very important TSA for maintaining turn-around-time of deliverables, reasonable cost and good relationship to improve further in business. After selecting the TPVL through a request for proposal process, it is good to assess the requirements and specifications, risk, implementation planning and scheduling for data transfer. Once the clinical protocol is approved, sponsors engage in discussions with TPVL regarding the data transfer agreement (DTA), file format specifications and data cleaning plan.

Implementing the procedures for collecting, transferring, loading and validating and editing external laboratory data document is crucial for clinical data management [Figure 3].[4] Figure 3 Setup process for collection and transfer of laboratory data Laboratory data is reconciled with site data during study conduct and any discrepancies are resolved with the laboratory vendor. Best practices during study conduct include automation of checks for data and for reconciliation, streamlining query resolution process and implementation of issue trackers to track issues for future use to update standards and process. Finally, the third party data is placed in a central repository for further analysis. CHALLENGES WITH TPVL There are many reasons for slippage in third party data transfer to data management group (DMG) during the conduct and closeout phase of the study.

Of these, delay in receipt and poor quality of data leading to rejection or rework can account for more than 50% of reasons for the delay in database lock due to the laboratory issues. Other causes in delay are normal ranges for laboratory data, especially when local laboratories in use are not available, data entry issues and delays in responses to Drug_discovery data queries, errors during data transfer and merger and discrepancies due to poor setup of database. Quality of deliverables should be continuously monitored using key performance indicators from study start up to closeout. Poor quality in interpretation of results or missing the delivery schedule will affect the timelines of the study, which can cause late submission of clinical study report to regulatory authorities.

Data managers are expected to look for the delay in processing the TPVL data address issues identified during reconciliation, communicate the timelines to the vendor and ensure common understanding between various stakeholders in order to ensure timely inclusion of laboratory data before database lock. inhibitor Nutlin-3a Efficient communication and good relationship with vendor can help in planning the schedules and steps to ensure timeliness of receipt of data.