According to recent trends reports¹, contract research organization (CRO) outsourcing is expected to grow to 35% by 2018 and up to 60% in the longer term. Due to the increasing involvement of CROs in clinical research, and their highly concentrated expertise in the latest technologies, all types of clinical design, geographical areas, therapeutic areas and regulations—contract research support providers are increasingly considered as strategic partners to Sponsors and have a growing impact on overall study direction and success. The quality of the relationship between Sponsors and CROs is therefore of the highest importance and actions to maximize the prospects of an effective partnership should be implemented at the very beginning of the project, that is, at the time of CRO selection. This article provides tips based on our experience to better plan for a successful Sponsor-CRO relationship across study phases, therapeutic areas, and projects.

Selection of a CRO can appear to be a daunting task. Sponsors have limited time available to research companies and dedicate to the selection process, and the CRO market now counts more than 3,100 providers² in the U.S. alone. Despite these challenges, 67% of Sponsors declare relying on industry research to select a CRO for their studies.³ In order to decide among CROs, sponsors most often evaluate a combination of factors, including technical approach, price, corporate and personnel experience, and other project-focused factors. However, it is also critical to consider further metrics, often cited as the major impediments to a successful sponsor-CRO relationship, including: communication strategies and quality assurance/performance consistency metrics.

Challenge #1
Communication Strategies
Communication issues can prevent the Sponsor-CRO team from working efficiently together and have dramatic consequences on the overall project’s timeline and budget. This is especially true given that projects are, by nature, ever-changing. To ensure that evolving expectations are fulfilled, project challenges are detected early, and informed decisions are made, planning for efficient communication should take place at the early stage of project design. Inefficiencies in Sponsor-CRO communication are often inherent to differences in the companies’ culture and work habits and the following dysfunctions:

• Differences in the platforms and formats used to communicate. Some companies are more efficient communicating in writing (e.g., email, status report), while others favor periodic face-to-face team meetings. Similarly, one company may use an online collaboration portal, while another may prefer a paper-based system;
• Frequency of the communications is unfit for the project. Too little communication may lead to misunderstanding and mistakes, while too much communication can be perceived as a disturbance;
• Ambiguity about who needs to receive the information. Ambiguity occurs when networks and lines of communication have not been established and reporting is consequently unclear; and
• Ambiguity about what information is needed. Key information can often be lost in details. The type of information that is needed by the different parties at the different stages of the project must be defined to avoid any misunderstanding.

The key to successful communication is being able to provide the right information at the right time through the right channel and to the right people. In order to plan for such challenges, it is critical to create and implement a solid communication plan at the outset of the partnership. Sponsors should evaluate CROs’ experience and reputation for developing clear communication plans, and current project and customer communication SOPs. The plan should define the rules governing communications and include information such as the objectives of the plan, media and technologies to be used during the project, deliverables (e.g., status updates), communication frequency, as well as the lines of communication and a project staff directory. The plan should also identify potential delays and bottlenecks, and include metrics that will be used to assess CRO performance. Direct lines of communications should be implemented between the Sponsor and the CRO’s senior project management. This reduces the number of intermediaries, minimizes the level of noise, and improves comprehension and overall project communication. In addition, direct lines of communication promote transparency, accountability, and flexibility, which are also the foundation of a successful partnership. The final project communication plan should be agreed upon, implemented by both parties, and updated as the project evolves.

Another communication metric to consider is a company’s ability to communicate across cultures and geographic areas. Cross-cultural challenges include language, verbal communication styles (e.g., direct vs. indirect, explicit vs. implicit), cultural considerations (e.g., work ethics, work habits, time consideration), and non-verbal barriers. These challenges are becoming even more widespread with the popularization of large-scale, global clinical trials involving multinational partnerships. Often, a good understanding of someone’s language is not enough to avoid most misconceptions and misunderstandings. A CRO with culturally diverse and trained staff eases the collaboration process and ensures communication remains uninterrupted by accounting for and welcoming these differences.

Challenge #2                                                         
Quality Assurance/Performance Consistency
Quality assurance involves planned and systematic actions established to ensure the trial is performed and the data are generated, documented, and reported in compliance with GCP and applicable regulatory requirement(s) in a consistent, reliable fashion. The implementation of a quality management system (QMS) is a vital part of the medical product development value chain. Developing a QMS involves establishing a structure, responsibilities, resources, and operational strategies to ensure that quality expectations are met and SOPs are in place to mitigate compliance risks throughout GCP activities. A QMS helps to increase productivity by improving the use of time/resources and minimizing the need for rework, improves compliance and documentation, and achieves greater stability and reliability. CROs with an established, tested, and ISO-certified QMS can better ensure quality and performance consistency throughout and across projects.

Another component to consider when evaluating a CRO’s potential for providing proper QA and consistency across projects is by evaluating the CRO’s ability and methods for qualifying vendors. As part of good practices, CROs must have written procedures and a schedule to analyze and monitor vendors’ quality programs. These procedures may include retrospective qualification consisting of evaluating past performance, and periodic auditing of vendors’ facilities, quality systems, documentation (e.g., quality manuals and risk control plans), and processes such as those pertaining to regulatory compliance practices. Contractors should also be able to justify the selection of vendors based on the specific requirements of the project. Finally, it’s important to keep in mind that one size does not fit all and that in order to be successful across different projects, project phases, therapeutic areas, outsourcing models, and geographical areas, for example, the expertise and capabilities of different outsourcing partners may be needed.

Since it takes years to develop a new drug and clinical trials can be unpredictable, Sponsors should be able to count on their partner CROs and have a functional strategic partnership in the long run but also in times of crisis. Before engaging in a partnership, it is therefore crucial for Sponsors to spend time appraising potential CROs, including their ability to plan for effective communication and aptitudes for QA/performance consistency to avoid some of the most common relationship pitfalls. 

References

1. Hemavli Bali, Brigitte de Lima, Carrie Yang, 2013.  CROs (Contract Research Organizations) and Other Outsourced Pharmaceutical Support Services M&A Drivers and Trends Report.
2. IBISWorld, March 2015.  Contract Research Organizations Market Research Report.
3. Nice Insight, 2015. Nice Insight Pharmaceutical and Biotechnology Survey.
4. Contract Pharma, May 2015. 2015 Outsourcing Survey.

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Anais Colin is a communications specialist at Technical Resources International (TRI) with several years of experience in customer service and project management. Please visit www.tech-res.com for more information.