OUTSOURCING
relationship can be what excels your study forward or what helps you achieve a quicker than anticipated database lock. The lack of relationships with sites can also be what slows the trial. As a sponsor who has contracted with CROs, how do we maintain that relationship? Fostering of the site-sponsor relationship should be at the top of our list when conducting clinical trials – something that is often overlooked until it is too late. This relationship can be a challenge, especially if we have contracted with the CRO for site management. One idea that we need to embrace is that we are not taking the site management from our CRO partners, we are maintaining our organisation’s relationship with the site. In some cases, with sites or institutions we have not worked with previously, the development of the site-sponsor relationship can be vital to future partnerships and enhancement of our scientific learnings. Sites want to hear from a sponsor – it reinforces our commitment to the study and shows that the programme is important to us. A sponsor who is not visible to a site is often seen as uncommitted to the programme.
Simple measures for the biggest impact There are several ways to maintain the site- sponsor relationship, one of which is to demonstrate our commitment and involvement to a programme, without stepping on the toes of our CRO or devaluing the CRA’s role at the site. Often the simplest measures with our sites have the biggest impact. One way, and maybe the easiest way for us to demonstrate our commitment to a programme, is communication. Communication from a sponsor with our sites should start early and not be limited when there are issues with the site or when we need something from them. A welcome email when the site is selected after a prestudy site visit can be one of the best ways to demonstrate that, as a sponsor, we are involved in the trial. An email or phone call to the site when the first patient is screened or enrolled shows a participating site that we know our study. Also, ensuring that all communications are written from the sponsor representative, rather than a CRO personnel, goes a long way to show a sponsor’s involvement.
While communicating with our sites, we need to ensure that we show commitment – not
only when communicating with our sites, but also in our responses to them. It is easy to respond to a question with a simple answer; however, a response that provides details regarding the decision demonstrates that we value the site and their questions. If we are disinterested in our responses, unresponsive or are not responding in a timely manner with answers to our sites, we will receive less communication and engagement.
“Communication from a sponsor with our sites should start early and not be limited when there are issues with the site or when we need something from them.”
Another way to maintain the site-sponsor
relationship is being visible to the site. This does not mean virtually visible, this means physically visiting and getting to know the site and the staff, allowing the site to put a face to the name of the sponsor. It is ideal when a representative from clinical operations of a sponsor company can visit at least once. In my years of clinical research, I have found that having a member of clinical operations visit has helped form a more solid relationship with a site. Something as simple as attending a site initiation visit (SIV) can foster a better relationship. Often, especially when working with sites that are new to a sponsor, an on-site visit from the sponsor can be a means to introduce other members of the organisation, such as the medical liaison team. This introduction can assist in helping a newer site feel that they have an organisations’ full support. The third way a sponsor can maintain
the site-sponsor relationship is to ensure we are fully supporting them, making them feel heard, addressing concerns and being available when they need us. Sometimes, as a sponsor, we forget how busy these sites are and the red tape they encounter within their organisation. Anything we can do as a sponsor to understand their concerns, address them and eliminate challenging study processes will only build that site-sponsor relationship. If our impression expresses a lack of concern for a site’s challenges as a sponsor, we will only fall to the bottom of the list. Ensuring that we continually think with the site in mind will demonstrate that we are in this with them, rather than just wanting patients enrolled in the programme.
Outsourcing in Clinical Trials Handbook | 17
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