Rho. Webinar. Optimizing Sponsor/CRO Relationships. May 10, 2016.
Report by Roberta Alexander, Ph.D.
On May 10, Rho offered a free online webinar on Optimizing Sponsor/CRO relationships, led by Jamie Arnott and Kristen Snipes from Rho. Here, Dr. Roberta Alexander of SDCRN summarizes the key points of this valuable webinar. You may also view the webinar, free, on-demand, here.
Key Factors for a Good Relationship
Pharmaceutical companies often rely on the help and expertise of Contract Research Organizations (CROs) in the execution of their clinical trials. It is important for the success of the trial that the Sponsor and CRO have a good working relationship. Key factors influencing a good relationship are communication, reports, financial management, and oversight of the project. The ideal relationship is based on trust, honesty, and mutual respect; mindfulness; understanding diversity; open communication; and having one point of contact. Business etiquette requires that all parties are on time at meetings and phone calls; are responsible, reliable, and follow through; use technology appropriately; follow proper business writing etiquette; and display appropriate body language in face-to-face meetings.
Best Use of Technology in Communication
When it comes to the use of technology in communication, keep in mind that your preferred method of communication may not be the preferred method of the other party, and that certain forms of communication may be more appropriate in some circumstances than others. For example, e-mail may not be appropriate for a brainstorming discussion. On the other hand, people who are not fluent in English may prefer an e-mail message to a phone call. In any case, mind the time zone when scheduling meetings, and always be professional and use proper grammar and spelling when writing e-mails. Communication needs to be concise and accurate, and of the appropriate frequency. It may be necessary to interact frequently at the beginning of the study, and less frequently when the trial is steadily enrolling. Avoid using your cell phone during a business meeting, as it is too easy to get distracted and lose focus. Texting can be appropriate to quickly alert somebody of something (e.g., I sent you an email) but text messages are not documented, so they should not be used to communicate something that needs to be documented.
Needs of Sponsor and CRO
Both Sponsor and CRO have their own particular set of needs in the relationship. The Sponsor needs a clear communication pathway and transparency; points of escalation if there are concerns; confirmation of key staffing; and adherence to timelines. For the CRO, important points include receiving clear directives as well as a unified message; having a point of contact; identification of the stakeholders, as the decision maker may be different from the point of contact; and deciding if the Sponsor’s or the CRO’s standard operating procedures (SOPs) are to be followed. Confirmation of key staffing may be particularly important if the relationship becomes tenuous, as it may be necessary to escalate the situation, externally or internally, to resolve conflict.
Part of the interaction between Sponsor and CRO involves negotiation. Prepare appropriately for the negotiation discussion; define what is important to you; understand the other party’s desired outcome vs. what they really want; do not make assumptions; and enter the discussion with an open mind. Most importantly, listen and ask open questions such as: Why? What? How? For example, why is this important to you? What is important to you about this? Why do you think this would be the best approach? What impact will this have on you or the project? In a negotiation, establish rapport and build trust (saying yes is not always the best thing to do); review the issue by stating your understanding of the issue and make sure everybody is on the same page; be clear about options, and be open to their ideas. Above all, listen, and be respectful and professional! As much as possible, come to an agreement. However, if agreement is not possible, it is fine to say no. Do not say yes just to please the other party, and then not be able to deliver what you said you or your team would do. At the end of the conversation, wrap up what was discussed. If some information was not available and the conversation seems stuck, a second round of discussion may be necessary at a later time. Likewise, if the conversation becomes heated, it is better to end it and continue it at another time.
Although the Sponsor transfers some responsibilities to the CRO, the responsibility of the study ultimately falls on the Sponsor. Thus, the Sponsor has to oversee the study; however, it should not micro-manage.
Reports assure proper communication between the Sponsor and the CRO. Determine the study reporting requirements and deliver the reports as the other party prefers: some may prefer the report be sent via e-mail, while others may want the report uploaded to a website. Adjust the frequency and content of the report as needed, as the information provided has to be relevant — there is no point in sending a report if it does not contain new information. In any case, always communicate clearly and be transparent.
Practical Case Studies
Having a good relationship is always important. Learn people’s names and make personal connections whenever possible. Be an active listener and understand the other party’s view. Stay informed by, for example, reading press releases. Consider the key factors of cost, quality, and time. These considerations may be important in various situations. For example, if the project manager of your study goes on parental leave, establish a relationship with the new project manager and bring him/her up to speed. If the CRO has been selected for a “rescue study”, try to understand what went wrong with the previous CRO. Bear in mind that the Sponsor is frustrated and lost time and money, and evaluate ways to solve the problem. But do not say yes to things you cannot do, as that will only increase their frustration.
Other situations may involve the sites. The Sponsor may want to use a certain site that the CRO does not consider appropriate: ask open-ended questions to understand why the Sponsor wants to use that site. Asking questions helps to build trust and shows that you are an active participant in the study. The Sponsor may want to do site initiation visits (SIVs) before the study is granted Institutional Review Board (IRB) approval. The CRO has to provide, in this case, a clear risk-benefit profile. Sites that are far from approval may go through a change in personnel or may forget the training by the time approval is granted, and there may also be protocol changes. Thus, in general, it’s not a wise strategy to conduct SIV ahead of IRB approval. Nonetheless, if the Sponsor really wants to do this, that’s fine, as long as the implications are clear.
To summarize, a good Sponsor/CRO relationship is similar to other relationships in that is based on trust, understanding, and mutual respect.