On any given day we see the announcement of a new strategic partnership or global alliance. Outsourcing to CROs is no longer big news. However, there is plenty of buzz over how these partnerships are performing. With the mounting pressure for innovation and efficiency, sponsors need CROs more than ever in order to survive.
Yet numerous industry polls show that perceptions and expectations between both parties have not changed much over the years.The good news is that sponsors are recognizing the need for more effective collaboration with their CROs. They are striving toward simplification in outsourcing processes, improvement in clinical operations performance, and a streamlining of oversight. In many cases, they are introducing technology to solve some of these challenges.
Sponsors continue to express frustration that they don’t know what is going on with their study. They feel there is a lack of timely dissemination of information. Most importantly, they feel that CROs are not openly communicating with them when trials experience problems.
Conversely, CROs report a lack of clarity from sponsors in outlining their expectations, roles, and responsibilities. Yet it is expected that they should replicate the sponsors’ processes. Sponsors do not ask for input. Instead, they have a tendency to either micromanage every aspect of a trial or remain completely hands-off until problems arise.
Whether engaged in a long-term alliance, or a contract for one multi-year study, sponsors are going to have to establish more open communications. Sponsors need to create collaborative working environments that work for all parties. They will also have to be flexible in integrating their workflow. Even with all the technological advances, both parties often maintain different work processes, SOPs, and technologies. This contributes to poor communication and collaboration. Of course fixing this is easier said than done.
Not all companies have the luxury of dedicating resources to hiring alliance managers and change management specialists, or to overhaul their IT infrastructure. But we have seen an effective way to help bridge the sponsor-CRO communication gap through the use of out-of-the-box portal solutions, such as Microsoft SharePoint, with only minor customization required to meet the needs of the sponsor-CRO relationship. These solutions have been applied to standardizing SOP training, dashboard data review, automated task alerts and notification, secure document exchange, site selection, e-monitoring and electronic workflows to name but a few. A sponsor/CRO collaboration portal can go a long way to facilitate communication and data exchange. This should not be used as an opportunity to micromanage or point fingers, but rather as an opportunity to share in the identification and resolution of issues.
Successful Portal Implementation
While this sounds ideal, setting up a successful sponsor/CRO collaboration portal can be a challenge. Here are some considerations for successful portal implementation:
- Engage your CRO partner or preferred providers in the selection and oversight of the system build, including documentation of requirements, user acceptance testing, training, and rollout
- Share in the development of an electronic workflow – the interface and functionality should mirror the workflow of both parties
- Collaborate on what information the CRO needs to provide the sponsor and at what frequency
- Make the portal accessible by the CRO
- When it comes to SOPs and processes for managing a trial, consider defaulting to the CRO process, so long as the process is clear and approved by the sponsor
- Consider cultural differences when designing workflow, communication, and training