Annual Vendor Management in Clinical Trials

Question: Describe about the Annual Vendor Management in Clinical Trials? Answer: Introduction: Clinical trial is a research which requires group of people to examine the safety, tolerance, dose and action of a drug. Clinical trial obeys a pre- planned protocol. Clinical trial is also known as clinical research. Their actions or tissues are needed for the study of clinical research. So, full method is very critical to handle. A set of people or a specific person is required in clinical research. The life process management of vendor for standard procedure is very important in clinical research organization. The vendors are chosen by the pharmaceutical company based on certain criteria. Those criteria can be the proposal of the vendor, evaluation of the proposals, searching a perfect vendor, creating a contract negotiation strategy and analyzing the business requirement. Clinical trial is demanded for the development of new drug in the market. The vendor selection for clinical research is very important. The clinical research takes 10- 20 years to yield a new drug (Diahome.org, 2015). The safety and efficacy of investigational drug is very important. The vendor plays a chief role in the clinical research management. The pharmaceutical company is conducting the whole clinical research plan. And they should select a proper vendor for a specific reason (Clinicaltrialsummit.com, 2015). The protocol, agenda, standard and quality of the vendor should be up to the mark so that the clinical research plan will be executed properly. The criteria of the clinical research should meet the agenda of the vendor. It is important to select a proper vendor for a clinical research to continue the process and the outsource materials. A supporting vendor is needed for the clinical trial. The supporting vendor is called third party vendor. The commitment responsibilities with the vendor should meet throughout the process. So the vendor selection is very important to keep the quality and standard of the outsourcing product (Xtalks.com, 2015). Many companies are using third party vendor for their safety. The services of the clinical research organization, health care technology firms, data management and medical education vendors are recruited by the companies (SOP 02: Evaluation and Selection of a Clinical Trial Proposal for CESAR, 2003). There are some factors to choose a vendor for a clinical trial. The factors that need to be considered for vendor selection are efficacy, security, compliance, contract fulfillment and quality of the vendor. To get a proper result in time a vendor has so many duties. The policies and contracts should meet the criteria which have made primarily (Peace and Chen, 2011). If a vendor is not efficient enough to meet all the criteria at that time, a third party vendor is needed. The vendor activity is regulated for getting more prominent product by the clinical trial. The judgment should evaluate the inclusive performance of a third party vendor by firmly investigating their attachment to constitutional responsibilities and the potential of their procedure and controls (Progress in clinical trial, 2004). The third party vendor assessments are review of contract terms against work performed, program management, testing of selected documentation, on site audits of vendors, investigator eligibility and payments, compliance with the policies, procedures and practices of the company, compliance with the regulatory guidelines, accuracy of billing and invoices. All the materials used in the clinical trial are supplied by the vendors. So it is very important to choose a proper vendor for outsourcing. The vendor should choose according to the business needs. A suitable vendor selection is very important for a clinical trial management to get a proper result. There are some benefits for outsourcing models. And the benefits are previous relationship, preselected plan, understands our needs and efficiency. There are also some risks for outsourcing models. The risks are stuck in a poor relationship, not getting the best technology or the newest, higher price due to the lack of competitive tender. First the resource requirements are determined. After that outsourcing requirements are determined. After determining the ongoing vendor research is started. The vendor is contracted initially. After the agreement the request for proposal documents are prepared. The request for proposal document is sent to vendors. The document is evaluated by vendors. The contract reward is made and monitoring the contract. Conclusion: The vendor selection for clinical research is very important. Clinical trial is increasing in difficulty. Vendor is agency or person that markets services or goods to other company or someone in economical manufacture chain. In clinical trial vendor acts an important role. The vendor is chosen by the pharmaceutical company based on some criteria. Vendor qualification, contracts and selection are major thing for a clinical trial. The agenda of the vendor is fulfilled by the company so that they can contract with the company. References: Clinicaltrialsummit.com, (2015).CHI's Fourth Annual Vendor Management in Clinical Trials Conference - part of Clinical Trial Oversight Summit. [online] Available at: https://www.clinicaltrialsummit.com/Vendor-Management-Clinical-Trials/ [Accessed 10 Mar. 2015]. Diahome.org, (2015).CRO - Clinical Vendor Oversight: Vendor Life Cycle Management for Quality and Performance. [online] Available at: https://www.diahome.org/en/Meetings-and-Training/Find-Meetings-and-Training/Meeting-Details.aspx?ProductID=2124278EventType=In-Company%20Training [Accessed 10 Mar. 2015]. Oversight Summit. [online] Available at: https://www.clinicaltrialsummit.com/Vendor-Management-Clinical-Trials/ [Accessed 10 Mar. 2015]. [Accessed 10 Mar. 2015]. Peace, K. and Chen, D. (2011).Clinical trial methodology. Boca Raton: Chapman and Hall/CRC Press. Progress in clinical trial. (2004).Clin Cardiol, 27(6), pp.364-368. SOP 02: Evaluation and Selection of a Clinical Trial Proposal for CESAR. (2003).Onkologie, 26(Suppl. 6), pp.5-10. Xtalks.com,. (2015).Managing Vendors: Tips and Tricks for Pharma-Biotech Companies-Get What You Need While Cutting Costs. Retrieved 11 March 2015, from https://xtalks.com/xto426swiftwater.ashx