Clinical Development Models Maximize Efficiency and Decrease Cost
To date, large Contract Research Organizations (CROs) have stepped forward to support all aspects of a clinical development program. However, this isn’t always the best solution.
Three common concerns about current clinical development partners
On a daily basis, I speak with clients in the life sciences industry about their clinical trial programs. The three most common concerns about clinical development partners are:
1. Project team bait-and-switch
A team with vast experience in the target indication is at the pitch meeting, but when the project is approved often times the client is assigned another team that isn’t as specialized or experienced.
2. Lackluster service
Many clients at mid-to-small life sciences companies feel they get slower service and response times than large life sciences companies. Clients at mid-to-small life sciences companies tend to feel as though they aren’t as important and are frustrated because they aren’t getting the service they feel they deserve.
3. Plethora of change orders
Many clients feel they are constantly receiving change orders. This is extremely frustrating, especially since so much time is invested in putting the project contract together. Clients are left feeling as though they are being charged more and more, which erodes confidence in the CRO team.
A partnership model is a better solution
There is a better way to conduct clinical development programs, and it revolves around approaching clinical trials in a partnership model that includes experts in clinical trial management and monitoring, clinical data management, technology, investigative sites, and labs.
Many companies believe it is easier to work with a single CRO on a clinical development program, and that it is more complicated to work with several providers. This is simply not true. Often times with a large CRO, sponsors are working with teams from the same CRO organization that are spread all over the US and around the world. So, many sponsors are already using communication practices and project management tools to keep larger project teams aligned and updated.
Working with partners who are experts in their respective fields is critical to expediting clinical development programs. Experts in areas such as clinical data management, technology implementation, recruiting investigative sites, and providing lab services are the most qualified to guide sponsors on how best to handle issues in these areas. This can save sponsors time and money.
We’ve worked in partnership models providing clinical data management services for nearly 10 years. We work with our clients to think about how to collect data, leverage the best technology available and build a database to the system’s maximum potential in the planning phase. When the clinical program is up and running, we work closely with sponsors to proactively provide clinical data management activities in order to meet timelines, provide metrics and report in real-time to all partners.
Best practices for successful partnership models
To ensure success for your clinical development program, especially if it is conducted as a partnership, I have these suggestions:
- Clearly define roles and responsibilities for all partners.
- Integrate and align partners to ensure all parties are working toward the same goals, understand the challenges, and are committed to working together.
- Insist on transparency in sharing information with all partners regarding progress, delays, and challenges.
- Leverage best practices for building cross-functional teams.
The next time you’re planning a clinical program, think about doing it differently and engage experts in clinical data management to complement the rest of the CRO team.
Guest blog post submit by Bob Arnesen
Photo Credit: Flazingo Photos
- elluminate Helps in Clinical Data Management Around the World
- Data Conversion Increases Transparency in Data Reporting