Never underestimate the power of the first impression. For though we should not attach significance to it, we invariably do. This is especially true in clinical research.

I have always believed that pivotal first meetings with sponsor representatives or investigational sites set the precedent for future relationship development. What is first demonstrated has strongest recall for all participants, whether fair and accurate or not. The first significant interaction creates the foundation from which a partnership is created. Sustainable partnerships positively influence study conduct; struggling relationships negatively affect the entire study cycle.

Meetings That Impact Study Relationships

The contract research organization (CRO) study team is the epicenter for study conduct. They serve as the sponsor representative for study sites, providing study directives and support. They also liaise with the sponsor on behalf of investigational sites to resolve issues, answer questions and provide feedback.  The study team is the conduit for critical communication, and how the communication flow is structured determines the course.

Important meetings occur with the study team, sponsors, and investigational sites, outside of traditional monitoring plan parameters. They bolster communication and create/foster relationships. They serve a variety of purposes: to confirm proficiency of vendor partners, to strengthen relationships with strategically/scientifically important sites, and to build confidence/goodwill for struggling sites. These visits often serve as the introductory vehicle for key study players and require finesse to ensure success. For these reasons, all early interactions are something sponsor companies should pay close attention to. There are three, in particular, that should be mentioned:

  • Enrollment booster visits: The sponsor and clinical research associate (CRA) may complete a “goodwill” tour of sites struggling with enrollment. This tour is a good time to discuss site recruitment plans, strategize recruitment tactics employed by high enrolling sites, or obtain site feedback on endpoints or eligibility criteria that present a barrier to patient identification. These visits may also increase study visibility at the site.
  • Sponsor medical science liaison (MSL) visits: The MSL for a pharma company may attend a site evaluation/initiation visit or accompany a CRA to an additional monitoring visit to provide scientific expertise on the study compound. The MSL may also provide support to reinforce the relationship to key opinion leaders/sites.
  • Sponsor monitoring visits: These confirm the proficiency of vendor partners. It is also to ensure the CRAs are sufficiently evaluating potential sites, reviewing data, and communicating study endpoints.

Professionalism, Preparation, Enthusiasm, Follow Through (PPEF)

The contract research organization (CRO) study team is the epicenter for study conduct. They serve as the sponsor representative for study sites, providing study directives and support. They also liaise with the sponsor on behalf of investigational sites to resolve issues, answer questions and provide feedback.  The study team is the conduit for critical communication, and how the communication flow is structured determines the course.

Important meetings occur with the study team, sponsors, and investigational sites, outside of traditional monitoring plan parameters. They bolster communication and create/foster relationships. They serve a variety of purposes: to confirm proficiency of vendor partners, to strengthen relationships with strategically/scientifically important sites, and to build confidence/goodwill for struggling sites. These visits often serve as the introductory vehicle for key study players and require finesse to ensure success. For these reasons, all early interactions are something sponsor companies should pay close attention to. There are three, in particular, that should be mentioned:

  • Enrollment booster visits: The sponsor and clinical research associate (CRA) may complete a “goodwill” tour of sites struggling with enrollment. This tour is a good time to discuss site recruitment plans, strategize recruitment tactics employed by high enrolling sites, or obtain site feedback on endpoints or eligibility criteria that present a barrier to patient identification. These visits may also increase study visibility at the site.
  • Sponsor medical science liaison (MSL) visits: The MSL for a pharma company may attend a site evaluation/initiation visit or accompany a CRA to an additional monitoring visit to provide scientific expertise on the study compound. The MSL may also provide support to reinforce the relationship to key opinion leaders/sites.
  • Sponsor monitoring visits: These confirm the proficiency of vendor partners. It is also to ensure the CRAs are sufficiently evaluating potential sites, reviewing data, and communicating study endpoints.

Professionalism, Preparation, Enthusiasm, Follow Through (PPEF)

PPEF, the acronym of accountability in relationship development, has four critical elements to ensure a successful first meeting/visit. A CRO/study team member should strive to demonstrate these characteristics.

Professionalism

Professionalism should extend beyond requisite politeness — it includes small talk and rapport building. Sometimes small talk is overlooked in in the rush to impress clients. Rather, CRO/study team members should strive to connect with clients. Small talk breaks the ice and creates the comfort zone required for more complicated dialogue. It also allows individuals to get to know each other on a personal level. Many small courtesies are extended in the questions asked and answered. Taking a moment for others to introduce personality elements beyond their study role can validate interest in the person and not just their ability to resolve data queries or complete case report forms. The most successful accompanied sponsor visits I have experienced started with small talk that uncovered common interests (hobbies, interests, hometowns) and created that essential connection. If your CRO does not initiate this small talk, consider initiating it yourself.

Preparation

Preparation is also integral to building customer trust and confidence. The process of preparing for any type of sponsor/CRO visit is nearly as critical as the execution of said visit. The extra steps taken to understand nuances beyond basic protocol and study overview can elevate the perception of mere competency to confidence. This impression is not lost on investigational sites. Observing the organized communication of study endpoints and methodology that comes from a thorough preparation process by a CRA builds credibility for the impending sponsor/CRO study partnership. Observing this preparation by the CRO/study team is critical. A well-prepared CRO/study team should leave both the sponsor and sites impressed, which will have a positive impact on the relationships.

Many years ago, I was tasked with completing a series of evaluation visits for a sponsor who had been through several CROs. The sponsor representative was accompanying me to two of these critical visits, for the purpose of fostering relationships with key investigators. I also realized the unspoken reason for their presence was to confirm vendor proficiency in light their previous challenges.

I had one chance to establish a positive impression with this sponsor. To that end, I elevated my routine preparation process

  • I immediately emailed the sponsor representative, to introduce myself and provide site contact details.
  • I thanked them for attending the evaluation visit and informed them that investigational sites always benefited from their attendance.
  • I did additional research on the sponsor and its pipeline (available online) to ensure discussion topics.
  • Though it was just an evaluation visit, I reviewed the entire protocol and committed the schedule of assessments to memory
  • I practiced slide deck review until I felt confident and familiar with the key endpoints.
  • I arranged for the sponsor rep and I to meet before the visit to share my plan for visit conduct. I asked the sponsor for feedback and any additional information they wanted me to provide to the site
  • During the protocol endpoint and eligibility criteria review, I paused periodically to ask the sponsor and principal investigator for insight on specific points relevant to their expertise. This led to active discussions that served to better educate both sides.
  • The study design was elegant and effective, with minimal patient burden. I gave the sponsor this positive feedback, which was echoed by the investigational site.
  • During the facility tour, I make sure I complimented the site on its organized research policy and infrastructure. There is a reciprocal assessment during evaluation visits that is sometimes forgotten. While the CRA is assessing site capabilities, site management is assessing how the CRA conducts the visit, to determine if a future partnership with the sponsor. Positive feedback (when appropriate) and professionalism strengthen the desire for future relationships.
  • Finally, I emailed the sponsor the follow-up items from the visit that required their specific attention to resolve.

My immediate goal for this sponsor visit was to restore lost confidence by demonstrating a process that went above and beyond the expected checklist. Little things can make a huge difference. It is important to ensure your CRO representatives are demonstrating this level of preparation in their interactions with you.

Enthusiasm

Enthusiasm is integral to a positive impression. There is no better tool for inspiring development than enthusiasm for another’s creation. A close colleague once conducted an evaluation visit with a sponsor at an investigational site in a large metropolitan city. The sponsor had offices there and the principal investigator was a member of their advisory board. The site was spread across a series of buildings in the bustling downtown section, which required the MSL, CRA, and study coordinator to walk to various locations in the city to confirm lab/pharmacy/imaging capabilities. The CRA shared her enthusiasm about the visit with the attendees, which sparked a lively discourse about their shared passion for clinical research, the importance of the therapeutic area, and the potential for a strong partnership.  Enthusiasm can resonate with, and unite, those once separated by titles.

Follow-Through

Follow-through is the simplest and most important step to fulfilment. When working with CROs and sites, sponsors should expect return calls the same day and emails within hours. Your partners should commit to following up on unresolved queries/questions/issues until resolved. They should give updates to client partners to assure their comfort with progress towards resolution. They should also be responsive and courteous on the path to relationship development and continue that far after the relationship is established.

CRO Oversight Post ICH GCP E6 (R2) Addendum

Risk management practices are now expected to be incorporated into the selection and oversight of CROs and other vendors. Find out more in SAM Sather’s webinar.

Conclusion

In clinical outsourcing, relationships are everything. Our connections structure the foundation of our partnerships, and the success of these partnerships drives study progress. The first impression provides a glimpse of future performance — your CRO partners should be treating early interactions as important opportunity to build confidence with you and with study sites.

About The Author:

Elizabeth Weeks-Rowe, LVN, CCRA, has 20 years of clinical research experience, including work as a study coordinator, CRA, CRA trainer, and CRA manager. She has been an Association of Clinical Research Professionals (ACRP) Certified Clinical Research Associate (CCRA) since 2004. Weeks-Rowe is a frequent speaker at clinical research industry conferences, as well as a requested speaker at both ACRP and SOCRA local chapter events. She has written numerous articles for ACRP and CenterWatch publications, and she completed the 2016 and 2018 updates to The CRAs Guide to Monitoring Clinical Research and the 2019 updates to The PIs Guide to Conducting Clinical Research, both from CenterWatch. She is a staff instructor for a clinical research training company and works in site evaluation and education in the CRO industry.

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