Dr. Fox speaks with Darshan Kulkarni about Optimizing Sponsor Practices for Site Partnerships. CRPN’s business model is designed to offer fair and competitive opportunities for sites, sponsors, and CROs for an efficient and high-quality research industry.
In this conversation, we discuss with Dr. Daniel Fox about the situation and the issues that the sites face on the ground. Sites deal with issues like miscommunication, breach of contract and lack of support during a #clinicaltrial. We talk about how the sponsor/Clinical Research Organization (CRO) can help and support the site in the long-run. This will prove beneficial to all the stakeholders involved. Site- Sponsor Relationship:
- The question whether the sponsor or the Clinical Research Organization (CRO) that represents the sponsor actually considers the site as a partner still exists. This leads to delays and unnecessary problems during a clinical trial.
- Good site-sponsor relationship leads to a transparent and more productive clinical research for the patients.
Also, it is an on-going process. Issues faced by the Sites:
Miscommunication with the Sponsor:
- Many a time, the sponsor delegates its responsibility of dealing with the site to the CRO.
- The CRO handles the budget, contract and the other negotiations with the site. However, the CRO at times asks for clarity or approval from the sponsor. The issue is that the CRO does not guarantee when they will come back with the clarity or approval from the sponsor. This shows that there is lack of communication between the site and the sponsor.
What can the Sponsor and the Site do to improve communication?
- There is a need for the site, sponsor and other stakeholders to have a direct contact method. It will be beneficial if a secure communication portal is in place. This will enable the site to get clarity from the sponsor whenever required. The sponsor will also feel more involved and engaged in the clinical trial.
- It will be useful if the site and the sponsor work on setting up a combination of mediums to improve communication. They can opt for a secure portal to deal with requests/issues that are not urgent. On the other hand, they can use emails/calls etc. for requests/issues that need urgent attention.
- It is important to note that the site is carrying out many trials at a time. Similarly, the sponsor can also be working with many sites at a time. It is therefore, important to use communication methods/mediums that are agreed upon by both, the site and the sponsor.
Lack of Support/Trust from the Sponsor:
- Often, the sponsor ends up treating the clinical site as a vendor who can be replaced if he/she does not obey the sponsor.
- The sponsors at times, do not adhere to the terms of the contract which has been executed between the site and the sponsor. In case of breach of contract, the site does not usually have a way out. This puts the site in an adverse situation.
What can the Sponsor do to Support/Trust the Site?
- Before contracting with the site, the sponsor does the site feasibility and the necessary due diligence. Therefore, it is important that the sponsor considers the site as a partner and not just a vendor who can be replaced. They should focus on achieving their shared goal of making the clinical trial a success.
- In order to support the site, the sponsor should fulfill the promises specified in the contract.
The Clinical Research Industry is growing exponentially. It is crucial that the site and the sponsor #worktogether as a #team .
