Startup
While the definition varies across companies, study startup typically includes the process of identifying and qualifying sites, collecting essential documents at the study and site level, and submitting these documents for ethics approval. Successful study startup requires coordination between sites, sponsors, and contract research organizations (CROs) to achieve critical milestones in a compliant manner.
- Site feasibility
- Regulatory reviews
- Study activation services for sites
- Optimize site training
- eRegulatory mangement and eConsent
- Document collection, distribution, and exchange
- Patient referral and recruitment management
Site Feasibility
Site feasibility is the process of evaluating the possibility of conducting a clinical trial or study at a particular site. The process aims at ensuring the proposed clinical site can conduct the trial, within the budget and the timeline, while maintaining data integrity and participant safety.
Surveying sites in a centralized manner — versus fragmented processes like emails and other portal(s) — enables sponsors and CROs to monitor and store real-time response rates and survey results while minimizing burden and redundant data requests of sites. Advarra’s Study Startup solution enables sponsors and CROs to gather critical information about potential site partners with a workflow tool combining multiple site lists, routes for review/approval, and tracks site status.
Independent Review Committees
Clinical research involving human participants typically involves some type of risk. Incorporating the appropriate research and ethics reviews and oversight helps ensure data integrity, and regulatory compliance. With 12,000+ protocols overseen annually, Advarra is #1 in trusted research review services.
Faster Startup With Study Activation Services for Sites
Advarra knows time is of the essence, making it crucial to ensure a quicker study activation process. Our Professional Services allows organizations to focus on what matters the most: research.
Optimize Site Training
A successful study requires sites to execute the protocol compliantly. Complex protocols, staffing challenges, and an increase in deviations threaten site compliance. As site staffing challenges persist, it is also essential to ensure access to training materials after initial activation to ensure the protocol is being executed correctly.
The study training solution supports site staff with study-specific training, including task and event-based training deployment, assessment and certification, and oversight into training completion. Sites using Advarra reduced protocol deviations by 21% versus sites not using Advarra on the same study.
Sites who use Advarra achieve over 89% training compliance throughout a trial including training beyond initial activation.
Related Solutions
eRegulatory Management and eConsent
Clinical research sites need to efficiently handle the complex documentation required for compliance with regulatory standards. Advarra eReg streamlines the management of essential documents, facilitates remote monitoring, and efficiently routes documents and facilitates electronic signatures. It seamlessly connects with site clinical trial management system (CTMS), eIRB, and email systems, as well as a sponsor electronic trial master file (eTMF).
For sites requiring an electronic consenting solution, Advarra eReg offers an integrated eConsent module to improve the patient experience and simplify the consent process for site staff.
3 million +
documents managed by eReg
Seamless Document Collection, Distribution, and Exchange
Accelerate study startup via end-to-end integration and automated, seamless exchange of research documents between sites, sponsors, and CROs.
With Advarra’s Document Exchange platform, create reusable document request templates to expedite and standardize study startup document collection. Easily track and monitor status of documents and requests, while automating the flow of all relevant documents to the appropriate eTMF throughout the course of the study.
“Document exchange has been a pain point for sites, often resulting in duplicative work and additional training burden for our staff who have to learn a different system for each sponsor. Giving our research teams the ability to leverage regulatory integrations to share documents with sponsors will be a game-changer, particularly during study startup.”
Denise Snyder
Dean of Clinical Research, Duke University
Patient Enrollment Planning
To enroll a patient into the trial, site staff must manage patient referrals, prescreen patients to determine eligibility, and consent the patient.
However, nearly 80% of all trials fail to meet their original enrollment deadline and over 50% of trials fail to meet enrollment targets. Advarra’s enrollment planning solution supports participants on their study journey with information and resources they need to be informed, compliant, and retained. All while enabling site and sponsor teams with better visibility into recruitment progress and tools to quickly find, screen, and consent each potential participant.
When using Advarra’s solution, sites are 27% more likely to achieve recruitment targets regardless of study/phase/therapeutic area.
