Clinical trials pave the way for medical advancements, leading to cutting-edge treatments that dramatically improve the lives of patients. This is one of the reasons some sponsors want to support clinical research, as it gives them the chance to make healthcare history.
However, sponsors must ensure they have the proper foundation for sound clinical research. Ultimately, all of the aspects of running a trial – from recruitment through completion – are complex undertakings, and getting them right is essential. With that in mind, here’s an overview of a sponsor’s responsibilities and our top five tips sponsors should know before running a clinical trial.
What Are Sponsor Responsibilities in Clinical Trials?
Sponsors are individuals, institutions, or organizations that initiate, manage, and finance clinical research. Generally, sponsor responsibilities include, but are not limited to:
- Selecting and preparing investigators, sites, and contract research organizations (CROs)
- Developing standard operating procedures (SOPs) and protocols
- Aligning studies with good clinical practice (GCP)
- Ensuring compliance with various regulatory requirements
- Setting up the data safety and monitoring board (DSMB)
- Establish quality control and quality assurance systems
- Risk-based monitoring and auditing
- Adverse event tracking and safety evaluations
- Report creation and submission
In some cases, sponsors pull double duty, acting as principal investigators or similar persons who conduct the clinical research. However, such involvement isn’t inherent to the role of the sponsor. With sponsor responsibilities explained, here are the top five tips sponsors should know before running a clinical trial.
1. Select a Tech-Enabled CRO
When selecting a CRO, choosing a CRO that embraces advanced technologies can improve the efficiency of your clinical trial from start to finish. Tasks like data management are often cumbersome without a capable tech stack, making a partnership with a tech-enabled CRO wise.
There are also benefits of working with a small CRO that’s tech-focused. At Vial, we take advantage of an array of cutting-edge technologies, including:
- EDF (Electronic data capture)
- ePRO (Electronic patient-reported outcome)
- eSource (Electronic source)
- eTMF (Electronic trial master file)
- CTMS such as VialConnect
Ultimately, the right technology solutions are essential for streamlining clinical research, making data collection, compliance, and other responsibilities easier to manage. By choosing a tech-enabled CRO, you’re setting your trial up for success!
2. Develop a Risk Management Plan
Risk is part of the equation in any clinical trial. It is common for things not to go as expected, which is why preparing an effective risk management strategy is critical.
Overall, a risk management plan needs to include:
- Realistic timelines for all stages of the clinical trial
- Feasibility assessments to evaluate risks
- Action plans relating to managing unexpected events
- Auditing and monitoring processes for continuous use during the clinical trial
A risk management plan allows you to prepare for potentialities before critical situations occur. With a plan in place, you can act proactively instead of reactively, making it easier to adjust to the unexpected.
3. Create Transparent and Collaborative Partnerships
Openness and transparency are the foundations of communicative, collaborative partnerships. When information flows freely and accurately, everyone overseeing the clinical trial aligns their actions with the same priorities and understanding. Along with avoiding potential miscommunications, this streamlines clinical research by eliminating the need for corrective actions based on inaccurate information.
Throughout the process, sponsors should be transparent and communicative with their CRO about trial needs, study scopes, and the overall budget. Additionally, sponsors and CROs must work collaboratively to create data-driven strategies and workflows to enhance efficiency and accuracy.
Being open with site staff is similarly vital. Ultimately, the site staff are the ones doing the legwork, so ensuring they’re working off of accurate information and relaying details appropriately is a must.
4. Design Patient-Centric Trials
Patient centricity allows you to create a clinical trial that focuses on the experience of human subjects. It ensures their needs and perspectives are appropriately taken into account, effectively making them a part of the decision-making equation.
With patient-centric clinical trials, recruitment and retention are easier to manage. As a result, finding enough participants and keeping them engaged is simpler, ultimately shortening timelines and improving overall efficiency.
5. Stay on Budget with Fixed-Pricing
Clinical research projects often struggle to stay on budget for several reasons. Unexpected delays, patient dropouts, and change orders can all lead to overages, potentially to the detriment of the trial.
Change orders are a leading cause of unexpected charges. By choosing a CRO with fixed-fee pricing, you can avoid change orders, as well as get several benefits, including:
- Shared risk responsibility
- More open communication
- Stronger relationships between CROs and sponsors
- Incentivizing the CRO to follow timelines
Ultimately, choosing the right tech-enabled CRO with fixed-fee pricing provides sponsors many benefits. Along with predictable pricing, Vial can conduct patient-centric trials efficiently, all while ensuring full transparency and open communication to help you reduce risk.
To learn more about what Vial has to offer, request a quote or connect with a team member today!