Ekaterina Bulaeva

With the ever-growing trend in pharma to outsource clinical research to CROs, optimizing this partnership becomes essential for maximizing its benefits. Successful interaction among all the members of such a collaboration is key to accomplishing mutual goals. But every interaction requires skills in communication and relationship management to create a shared vision of strategic partnering and trust. Each stage of the process has its own benefits and risks, and each pain point while collaborating refers to a specific problem that relevant parties are facing.

Inefficient interaction between sponsors and CROs can hold back the quality of clinical trial data and compromise research outcome. To further analyze the specifics of the CRO-Sponsor communication, OCT Clinical, a European CRO, launched a survey among industry professionals involved in clinical trials across the US and Europe to get first-hand data from the immediate participants of such partnerships.

The survey was fielded among OCT Clinical’s customer and partner databases of over 8,000 contacts. Email invitations were sent out to fill out the survey in Microsoft Forms. As a note of appreciation, the respondents were offered Starbucks gift vouchers. The survey was split into two main categories according to the types of respondents. CROs and pharmaceutical/biotech companies. Overall, 320 respondents across both areas provided thorough replies which were further analyzed to get presented in this article. The aim of the research was to explore the CRO-Sponsor collaboration scenarios and to identify key challenges, weak points, and best practices for each group.

Such surveys are aimed at creating a “win-win” approach for both parties. Sponsors would benefit from more robust and feasible plans, procedural efficiency, and decreased costs, while CROs would get an increasingly reliable and longer-term revenue stream by providing additional value and expanding its service offerings.

The role of CROs is becoming increasingly significant in treatment development as they become more involved in clinical research and are seen more as strategic partners, providing access not only to specialized expertise, but also to patients around the world. According to the aforementioned survey, 81% of respondents indicated CRO-sponsor relationships as 'Very Important' or 'Important' in pharmaceutical research. From the table below we can see that almost 87 % of respondents among Sponsors believe that “meeting project timelines on time” is the number one criteria for evaluating CRO performance.

In addition, “Recruitment fails”, “not delivering according to plan” and “inefficient communication” were mentioned as the most common barriers to successful collaboration between CROs and pharma companies.

Almost 45% of the respondents graded their experience with their current CRO as moderately or completely unsatisfactory. It is worth mentioning however that, there is no apparent difference between working with a global or local CRO, since 60% of those not completely satisfied with their current partnerships work with global CROs.

Hence, one of the most critical insights is that collaboration with global industry players is not a panacea.

In response to the question: “What are the most frustrating/challenging issues when working with a clinical CRO?”, which had the option of an expanded answer, the following statement/points headed the list: quality issues (lack of understanding of therapeutic areas), recruitment issues (finding qualified sites, poor site selection) and communication issues. Illustrative examples are outlined below by expanded answers from Sponsors:

“Staff retention, particularly key employee turnover. Lack of relevant manpower in the company. They don't give their staff time to properly read and truly understand the trials.”

“Non-transparent budget. Unclear overshoot.”

“CROs don’t like to problem-solve and offer suggestions. They’d rather just do as they are told.”

“Lack of attention and lack of proactive thinking. Resulting in unfulfilled promises."

“Holding them accountable for the feasibility is an issue. Feeling disconnected from the sites.”

“Staff turnover, incomplete information.”

This points to the fact that better engagement and strong relationships come from transparency and trust. Once a vision with values and objectives has been established, additional aspects of the partnership and operating strategy can be defined so that both parties build trust through a combination of integrated goals, structure, resources, processes, technology, and metrics.

A separate section of the survey was devoted to the study startup challenges from the perspective of Sponsors. The most common issues here were the following:

The inaccuracies which can occur in CRO-pharma communication can go both ways. While each clinical research project is unique, CRO representatives who have also been surveyed for this article mentioned certain common challenges which originate at the Sponsors’ end. Among the top frequent concerns that the CRO representatives mentioned were: quality issues such as lack of accuracy in study designs and protocols (57% of respondents), lack of understanding of the specifics within certain therapeutic areas and indications (34%) and communication issues such as insufficient or untimely responses (23%).

Incomplete information provided by sponsors is a big barrier to successful collaboration between CROs and pharma.The challenge increases significantly when a sponsor contracts several CROs for a single project.

“A lack of adequate time for the RFP process.”

“Not enough planning, risk management, informative reporting, effective communication and governance structure.”

“One sponsor that I work with is new to fully outsourced trials, so at the beginning of our working relationship they micromanaged us.”

“Insufficient planning and risk management, inefficient communication and management structure.”

“Different understanding of process management, different expectations for interaction processes.”

“Sponsors do not give us responsibility for the decisions we should take. This delays our results, which sponsors will hold us accountable for in the end.”

Uncertainty about responsibilities and decision authority causes major barriers to maximizing potential benefits. The following conclusions can be drawn from the analysis of this survey:

Make sure your team can effectively handle situations like differences in expectations, and understanding of responsibilities. Start with the simplest: calendar meetings—will they be weekly or monthly? Decide and plan your roadmap and get all activities on everyone's calendar. Being proactive in communication can not only improve partnerships and your client commitment but also avoid delays in responses, which can result in delays in the whole clinical research process. Today it is more important than ever to maintain lines of communication, and occasional videoconferencing is a great facilitator in times of limited travel. According to the survey, 58% respondents use applications such as Zoom, Skype, or Teams on a regular basis.

Make a point of “whose SOPs to follow” clear from the start. If a sponsor fully outsources a set of activities to a CRO, CRO’s SOPs could be used as primary ones. In this case, there will be no need to organize additional training for CRO’s team.

Prioritizing opportunities and creating a common vision and goals for the partnership form part of the next important stage in negotiations. Sponsors and their CRO partners can determine the type of relationship they want to establish for both near-term and longer-term objectives. CROs, for their part, require skills in communication and relationship management to create a shared vision of partnering and trust.

Remember to be a partner, not just a vendor, as a clinical trial process is a mutual well-defined commitment to a collaboration. From the very beginning, this is your chance to contribute to a mutually beneficial long-term relationship. Understanding the points discussed above can help prevent barriers from happening.

Considering the above-mentioned points will help create a “win-win” situation for both parties, with a mix of both tactical and strategic elements. The sponsor would benefit from more robust and feasible plans, process efficiencies and decreased costs, and the CRO partner would get to work on new exciting projects and secure great partnerships, by providing additional value and expanding its service offerings.

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Survey taken by CROs and pharma/biotech companies seeks answers in maximizing partnership.

Ekaterina Bulaeva

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