Strategic Vendor Selection in Clinical Trials: Sponsor's Guide

This report investigates the critical role of proper vendor selection in clinical trial outsourcing, emphasizing its importance for standardization, partnerships, financial stability, safety, and efficacy. It highlights that the increasing reliance on Contract Research Organizations (CROs) necessitates careful selection processes. The report details a five-step approach for sponsors when engaging CROs, including wise CRO selection, qualification analysis, evaluation reviews, thorough investigations, and consideration of technical and operational aspects. The study underscores that a well-chosen vendor is essential for maintaining quality standards, ensuring safety, fostering healthy partnerships, and achieving financial stability in clinical trials. This document is available on Desklib, a platform offering a wide range of study resources, including past papers and solved assignments, to support students' academic needs.

Research Project
Why is proper vendor selection important in clinical trial outsourcing? What
points is a sponsor likely to consider when selecting a contract research
organization to conduct their clinical trial?
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Research Project
Table of Contents
Introduction........................................................................................................................ 3
Discussion............................................................................................................................ 3
Importance of selection proper vendor in clinical trial outsourcing.......................3
Points to remember for sponsor while selecting contract research organisation
........................................................................................................................................................ 5
Conclusion........................................................................................................................... 6
References........................................................................................................................... 7
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Research Project
Introduction
Outsourcing is a business-to-business process or practice where one company
hire another company to perform any work (operations, products, services etc.)
depending on their requirement. The implementation of this outsourcing practice by
medical firms is termed as clinical outsourcing where pharmaceutical, medical and
biotech companies’ reliance on contract research organizations (CROs) for their
clinical research activities (1).
This outsourcing business relationship is dependant on the sponsor and vendor
involved in the deal. In simple terminology, the sponsor is basically the person or
organization that hires the CRO whereas vendor is person or organization getting
hired by the sponsor. This research project details a study on requirements of proper
vendor selection while outsourcing a clinical trial and point sponsor need to consider
while hiring a CRO for outsourcing deal.
Discussion
Importance of selection proper vendor in clinical trial outsourcing
In previous times, outsourcing in the clinical trial was performed for non-
critical and unimportant services/products but from last few decades outsourcing is
considered critical good practice for product manufacturing and clinical processes.
More and more reliance on Clinical Research Organizations (CROs) is increasing
with time for important and essential services/products outsourced from these CROS
for improved productivity and efficiency. This initiated an increase in consciousness
while selecting these CROs and vendors for clinical outsourcing (2,3). According to
Brinkkemper et al. (4) study, there was a recent survey performed with sponsoring
pharmaceutical companies regarding the importance of selecting a proper service
provider. As per survey findings the importance of selecting proper vendor and CRO
is listed as Confidentiality (83%), quality (80%), performance consistency (78%),
compliance (75%), timeliness (60%), financial stability (59%) and project cost-
effectiveness (55%). Oshri et al. (5) stated that as per viewpoint of more than 50%
pharmaceutical companies as per their experience, improper vendor selection results
in poor product/service quality, unmatched chemistry (sponsor/vendor), inexperience
regulatory requirements, lack of skills and instability (80% of vendor not able to keep
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Research Project
their commitments).
Maintaining standardization
For contemporary pharmaceutical companies in the era of competition and
options, ‘maintaining standard’ is a key to success. However, while outsourcing
clinical trials they put their standardization as a point of risk. Therefore, the selection
of proper vendor as per sponsor’s quality standards is an initial requirement for
making any outsourcing deal (5,6). According to Kaufmann et al. (7) studies the
functionality of company depends on the vision of its mentor especially for companies
involved in outsourcing the vision of mentor is considered as a subjective presentation
of their company’s standard. Basically, in an outsourcing deal, vendor vision and
standard works as a presentation of their organisation. Therefore, a sponsor needs to
agree with vendor’s vision in any outsourcing deal to maintain their business standard
in future. Tsou (8) indicated that points or features defining quality standards in CRO
clinical trail functionality are CRO’s work, data management, clinical monitoring,
statistics and safety data signals.
To assure safety and efficacy
The clinical trial work involves hazardous materials, scientific information,
sensitive information, semi-furbished drugs/medicines and other sensitive dealings;
therefore, sponsor company needs to have a trust established with their outsourcing
vendor to assure safety and efficacy in the clinical trial. The outsourcing supply chain
also involves third-party vendors, therefore, safety and efficacy is a major concern for
Sponsor Company before getting involved in any outsourcing deal (2). According to
Roy et al. (9) studies, vendor market reputation and stability is a workable tool to
identify the efficacy offered by their organization. Usually, the critics are right about
the market information of any vendor (91%). This makes vendor selection a more
important and sensitive matter of concern for sponsor organisation.
Effective and healthy partnership
As per Lustig et al. (10) studies, commitment from both sides is essential for
the functionality of outsourcing service model. It takes about minimum 2years to
establish a stable partnership between sponsor and vendor in any clinical outsourcing
deal. Therefore, selection of proper vendor is important to assure commitment,
effective and healthy partnership without the wastage of time and money. According
to Oshri et al. (5) knowledge, vendor’s effective leadership and operational staff
potential are essential elements for matching chemistry between the sponsor team and
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Research Project
vendor team. Therefore, to establish long-term effective and healthy partnership, the
sponsor needs to determine the leadership and management of vendor in the
outsourcing deal.
Financial stability
The statistical information about financial outcomes related to outsourcing
clinical trials indicate a 20-25% savings in cost in the last 15 to 20 years reported by
more than 10 thousand pharmaceuticals globally. The major features delivering this
cost savings are simpler administration, project management activities, less
production cost and commitment stability performed by the vendor of CRO.
Therefore, selection of proper vendor regarding outsourcing deal also assures
financial stability to the sponsor company (11).
Points to remember for sponsor while selecting contract research organisation
In the contemporary era of revolution and transformations, both small biotech
and larger pharmaceuticals like to outsource to CROs for their clinical trials. In 2016,
Contract Pharma Company performed a survey as per which out of 315
pharmaceutical companies 80% were interested in increasing their clinical work
outsourcing in the coming future. However, more than 60% of companies faced the
issue in criteria to outsource CROs reporting defects in their selection process. Hence,
study findings indicate that outsourcing CROs is a complicated process that requires
professional guidance to promising future of outsourcing industry (12).
According to Lustig et al. (10) studies, the most commonly used five-step approach
that is generally followed by most pharmaceutical companies to engage CROs in
outsourcing deal are described below: -
Step-1. Selection of CRO wisely
Selection of CRO for outsourcing is a combination of both science and art; the
science involves the determination of risk, business model, quality, ability, cost-
effectiveness and scientific capabilities. Further art involves the determination of
reputation, experience, history working relationship, timelessness and vendor vision.
The sponsor company needs to work wisely involving both science and art while
selecting a CRO (13).
Step -2. Qualification criteria
The sponsor company needs to establish a team of experts that would work to
select CRO on basis of their defined qualification criteria for their company (2). As
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Research Project
per Kaufmann et al. (7) studies, the qualification criteria varies from company to
company base don their requirement but the most common elements of this criteria
are location, areas of capabilities, market reputation, facility, policies and procedures,
management, security and leadership strategies.
Step -3 Reviewing current evaluations
According to Bhalla et al. (2) studies, sponsor company should establish
regular visit basis annually, quarterly or monthly as per their need to review CRO
records, staff, data quality, communication and confidentiality to ensure a proper
working and long-term relationships while making a outsource deal.
Step -4. The right investigation process
Sponsor Company needs to hire a professional investigator who can
investigate clinical processes performed by CRO in a professional manner having
expert knowledge. This process is very important for outsourcing clinical
products/services because mistakes in the procedure investigation can lead to health
hazards (13).
Step -5 Technical and Operational aspects
According to Getz et al. (3) studies, the sponsor needs to take care of certain
technical and operational aspect while dealing with CRO that involves contract
requirements; cost-effectiveness, performance, debt capacity and growth rate are
operational aspects. Further, technical aspects involve assessment of labour
operations, clinical site monitoring, laboratory hygiene and techniques.
Conclusion
While determining the research project question the study findings indicate
that proper vendor selection in any outsourcing deal is essential for standardization,
health partnership, financial stability, safety and efficacy of Sponsor Company.
Further, the sponsor needs to follow a stepwise approach while hiring a CRO for
outsourcing work that involves CRO wise selection, qualification analysis, reviewing
evaluations, right investigation, considering technical and operational aspects.
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References
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and other partners. CRC Press; 2016 May 13.
(2). Bhalla A, Terjesen S. Cannot make do without you: Outsourcing by knowledge-
intensive new firms in supplier networks. Industrial Marketing Management. 2013
Feb 1;42(2):166-79.
(3). Getz KA, Lamberti MJ, Kaitin KI. Taking the pulse of strategic outsourcing
relationships. Clinical therapeutics. 2014 Oct 1;36(10):1349-55.
(4). Brinkkemper S, Jansen S. Collaboration in outsourcing: A journey to quality.
Springer; 2016 Jan 6.
(5). Oshri I, Kotlarsky J, Willcocks LP. The Handbook of Global Outsourcing and
Offshoring 3rd Edition. Springer; 2015 Jan 23.
(6). Yeboah A. The relationship between outsourcing and organizational performance.
European Journal of Business and Management. 2013;5(2):2013.
(7). Kaufmann L, Wagner CM. Affective diversity and emotional intelligence in cross-
functional sourcing teams. Journal of Purchasing and Supply Management. 2017
Jan 1;23(1):5-16.
(8). Tsou JA. Managing biomarker outsourcing: CRO evaluation, streamline outsource
process, and quality management. InTranslating Molecular Biomarkers into
Clinical Assays 2016 (pp. 189-199). Springer, Cham.
(9). Roy S, Sivakumar K. Which controls are better for service outsourcing?
Integrating service-dominant logic and service characteristics. AMS review. 2014
Dec 1;4(3-4):45-62.
(10). Lustig K, Thompson M, Gul S. The evolution of the Contract Research
Organisation and the future of the pharmaceutical industry. Eur. Pharm. Rev..
2013;18:60-2.
(11). Keith B, Vitasek K, Manrodt K, Kling J. Selecting the Right Sourcing Business
Model For Your Situation. InStrategic Sourcing in the New Economy 2016 (pp.
189-217). Palgrave Macmillan, New York.
(12). Hajos AK. Trends and Innovations in Pharmaceutical R&D Outsourcing. Value
Creation in the Pharmaceutical Industry: The Critical Path to Innovation. 2016 Jan
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(13). Madsen TL, Walker G. Modern competitive strategy. McGraw Hill; 2016.
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