Study Startup (SSU) – which encompasses various critical steps required to start a study – is an inherently complex process with typical roadblocks. Given that the work involves professionals and experts across different locations and at various levels – sponsor, Contract Research Organization (CRO), and onsite, the initial scope of Study Startup (SSU) is hard to comprehend.
To add to these complexities, there are intrinsic challenges related to reduced margins, the impact of globalization, and complex regulatory requirements. To counter the bottlenecks, sponsors are now relying on an effective outsourcing model, which relies on Contract Research Organizations (CROs) to conduct clinical trials. Contract Research Organizations (CROs) have the tech advantage and are key innovators in facilitating clinical trials without innate infrastructural challenges. Sponsors can gain from the existing infrastructure investments and tech expertise of the CROs to reduce the costs of such clinical trials and streamline collaboration across different levels.
There are 9 critical steps in the Study Start-Up process, as identified by COSMOS-
- Identify Sites
- Contact Sites
- Execute the CDA
- Complete the Site Feasibility
- Complete the Pre-Site Visit (PSV)
- Initiate CTA / Budget
- Negotiate the CTA/Budget
- Regulatory Submissions
- Site Initiation Visit (SIV)
The success of clinical trials depends largely on the initial Study Start-Up process, and there is available data to show that a good initial start makes the room for successful trials. The Study Start-Up process is a complex one, which involves various tasks, including the investigator section, keeping a tab on ethical & regulatory requirements, site training, and initialization.
The Study Start-Up process is an indispensable part of all clinical studies and is marred by the need for extensive paperwork, multi-level approvals, and the land of adequate coordination between sites and sponsors.
What does it take to improve and accelerate the Study Start-Up process? After years of research and dialogue involving sponsors, CROs and sites, we have found 10 key steps that can enhance the approach. These steps can help clinical trial sponsors in fast-tracking the process of selecting and activating sites. We also have suggestions to improve these steps based on data.
Identifying high performing investigative sites
This is easily one of the most relevant, early decisions that clinical trial sponsors are expected to make. Identifying high-performing investigative sites is a critical factor in the timely recruitment and delivery of data without quality compromises. For sponsors, this is a time-consuming and laborious process, as it involves navigating and evaluating an enormous amount of data, determining patient accessibility, and finding potential sites for clinical studies.
The process also requires sponsors to collect and execute Confidentiality Disclosure Agreements (CDAs) with all selected sites, which largely determines the success and adherence to further timelines and milestones. Sponsors and CROs coordinate to simplify the process.
It requires a system that will allow the sponsors too
- Creating CDAs and sharing the same with sites and investigators
- Track the progress on CDAs
- Tenaciously track and monitor the feasibility of shortlisted sites
- Create alerts to update on missed timelines
What would an accelerated Study Start-Up mean to sponsors and PIs?
Sponsors, CROs, sites often deal with study backlogs and resource accounting, which cause unwanted study delays. Even with patients ready to enroll, principal investigators have to deal with delays in getting signed contracts and regulatory approvals.
With the dedicated COSMOS clinical trials platform, sponsors can minimize the turnaround time required for site identification, collection of study resources, contract & budget creation. It allows for easy enrollment and curtails issues related to resource allocation to focus on the study and clinical trial. COSMOS offers an exclusive Study Start-Up server with the platform, which empowers Sponsors/ CROs and Sites. The experts of COSMOS can further help with the study process.