Expedite Your Study Startup – A Site Checklist
Study startup and site activation are key to the clinical trial process, but often suffer from delays. It can be a time-consuming undertaking and requires multiple teams and moving parts to successfully begin a trial at the best sites for the protocol. In fact, a recent ACRP survey revealed that study startup was ranked among the top challenges facing clinical research sites.
While sponsors handle much of the initial study startup process such as protocol development, PROPEL is designed to help site organizations accelerate the aspects that they control. Custom-made for clinical trials, PROPEL offers study startup automation and organized workflows to accelerate the clinical trial process for sites and site networks.
Sites that have adopted PROPEL see almost 15 hours of time saved per study activation and 40% increased revenue. To assist sites and site networks in meeting targets, we’ve prepared a checklist that simplifies each step with tips to reduce potential delays and accelerate the study startup process.
Fast-Track Study Startup
PROPEL manages and optimizes every part of the site side of study startup. And with PROPEL, unlike paper or a CTMS, both pre- and post-award milestones can be tracked in the system by central teams or individual sites as trials progress.
1. Site Selection
Successful trials depend on sourcing the right-fit sites for study opportunities. Sponsors prioritize the identification of site locations with abundant resources, including staff expertise, facilities, and accessibility to the target subject population.
PRO TIP: To eliminate time spent on identifying sites with the relevant experience and resources, PROPEL’s query feature limits your search to only those sites matching the trial’s specific qualifications and capabilities. Opportunities and site responses are also centralized and tracked all in a single platform, simplifying oversight.
2. Confidential Disclosure Agreements (CDA)
CDAs are essential to ensuring the protection of sensitive information shared during the early stage of a clinical trial. A sponsor may choose to forward a protocol to the Principal Investigator (PI) for their consideration regarding trial participation. To protect confidential information within the protocol, the sponsor may issue a CDA.
PRO TIP: Using PROPEL, sites can organize CDAs by attaching them directly to a trial. This allows for easy access and reference. With the inclusion of Master CDAs by the sponsor or CRO, the process becomes even more efficient, enabling quick retrieval and comparison of key information.
PROPEL also tracks CDA status and completion by site, providing a comprehensive overview of the progress at each research site. This capability allows for effective monitoring of the CDA execution process, ensuring that all necessary parties have completed the required steps.
3. Feasibility
Sites are tasked with filling out and returning site feasibility questionnaires to aid in the selection process and uncover potential participation opportunities in new studies.
PRO TIP: PROPEL organizes this process by directly linking feasibility questionnaires to a trial and tracking completion by site. And with PROPEL’s Survey Feature, central teams can also create their own custom surveys and questionnaires, from feasibility and CSAT, to PI onboarding and equipment management. Surveys can be as general or specific as you want and for just about any use case.
4. Pre-Selection Visit (PSV)
A PSV is a meeting with a sponsor representative to assess if your site is capable and equipped to conduct a specific trial. During this critical step, sites that do not meet the necessary requirements for conducting the trial will be excluded.
PRO TIP: PROPEL enables sites to monitor PSV progress from requested to completed. For transparency and increased collaboration, users can share updates or missing items with the broader team for more support.
5. Award Letter
The next stage in the startup process centers around managing awards, particularly if you’re running a site network. An award letter triggers another series of intricate processes that includes reviewing or establishing accounts and providing documentation of deliverables stipulated in award documents.
PRO TIP: PROPEL uniquely streamlines this process, organizing which sites have been green lit for a study, and which are still working through pre-award milestones.
6. Contracts & Budgets
Contracts and budgets must be established prior to the initiation of a study at your clinical research site. Beyond managing the various contracts, including CDAs and Clinical Trial Agreements (CTAs), sites are tasked with developing a comprehensive budget outlining all expenses related to conducting a clinical trial. These tasks ensure compliance with regulatory requirements and promote responsible fiscal management for both the PI and the site.
PRO TIP: Rather than relying on traditional methods for managing this task, PROPEL is an innovative task manager that tracks the contract and budget progress, uploads relevant documents, and communicates updates and revisions. Leveraging PROPEL, sites can experience a reduction of up to 76% in contract and budget turnaround time.
7. Regulatory
Gathering and sharing essential documents during study startup is another stage where teams commonly face challenges that slow down the process.
PRO TIP: PROPEL effectively manages crucial regulatory milestones including Institutional Review Board (IRB) submissions, Informed Consent Form (ICF) preparations, and Site Initiation Visit (SIV) arrangements.
With PROPEL, sites can track completion dates for each milestone, allowing for a clear overview of progress and ensuring timely follow-ups when necessary. Sites can seamlessly upload and organize pertinent documents, creating a centralized repository that simplifies accessibility and enhances regulatory compliance. The system also facilitates seamless communication and collaboration through chat conversation threads that enable efficient information sharing.
Optimize Operations
PROPEL Enrollment Dashboard.
Once study startup is complete and the trial begins running at a site, PROPEL’s seamless integrations with leading CTMS such as RealTime, CRIO, and Clinical Conductor take over to track patient recruitment and enrollment. After the trial is completed, PROPEL further provides holistic trial performance metrics for site activities, enrollment, indications, and more.
With full oversight into real-time trial milestones and site activity, central teams can leverage key startup metrics and trial performance reports to identify bottlenecks – allowing them to quickly act to help struggling sites.
Key Benefits:
- Consolidate all your trial data, documents, and communication in one place.
- Keep central team members and site-based staff on the same page with powerful collaboration tools, eliminating needless emails, phone calls, and meetings inquiring about trial stages or updates.
- Centralize oversight of how trials are progressing.
- Share documents, tag users, and set custom alerts and reminders to keep tasks on track.
- By eliminating repetitive tasks and accelerating standard workflows with PROPEL, staff can spend more time on specialized tasks and patient-centric duties. Discover why the industry’s leading site networks have already adopted PROPEL. Startup up more studies faster and become a more competitive site organization with PROPEL.
Devana Solutions
Devana Solutions is an innovative cloud-based clinical trial software company that supports real-time collaboration between central research operations professionals and decentralized clinicians serving patients in diverse communities. Devana Solutions even bridges the technology access and data divide by seamlessly and securely connecting decentralized researchers to other mission-critical clinical trials systems.
Let us show you in more detail what Better Data, Better Decisions, Better Outcomes could do for your clinical trial processes. Book a demo with Devana Solutions today to learn about our cloud-based data analytics clinical trial software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.
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