To Enhance CNS Trials
Backed by over 25 years of global experience, unmatched CNS expertise, and cutting-edge tools, Clinilabs’ additional clinical trial services and technology are your pathway to CNS approval.
Trust the Neurotherapeutic Clinical Trial Experts
Clinilabs is the full-service CRO dedicated solely to CNS drug, device, and technology development. With more than 800 CNS clinical trials completed, and over 30 product approvals across more than 25 indications, we power our clinical trial services with unrivaled expertise.
Complementary Clinical Trial Services & Technology
Designed to accompany our clinical trial management solutions, our clinical trial services keep every synapse of your trial firing with focus, speed, and purpose.
Accelerator Sites™
Clinilabs has long-standing relationships with high-performing CNS research sites, offering rapid study startup and enabling us to meet enrollment milestones.
Our Accelerator Sites™ program represents a cadre of exceptional sites with:
- Pre-existing master service agreements and work order templates
- Guaranteed turnaround time for feasibility questionnaires
- Documentation of investigator site staff CVs, including rater certifications
- Rapid submission of IRB applications
- Rapid site activation, allowing us to guarantee the milestone for the first subject in
Clinilabs maintains and updates the profiles of all sites in our Accelerator Sites™ program, so we can move through the site selection process swiftly and activate sites early.
Placebo Response Management
CNS trials can have high placebo response rates, often leading to failed trials, increased development costs, and delays in bringing potentially effective medications, devices, and technologies to patients.
To mitigate the placebo response and minimize its impact on study outcomes, Clinilabs:
- Recommends proper education of site staff and patients regarding the study, use of placebo, and active treatments
- Ensures all parties are compliant with the protocol
- Implements management strategies aimed at protecting the primary and secondary endpoints
- Formally reviews risks and management strategies with the sponsor during team meetings or governance meetings to address any emerging issues proactively
Technology Accelerators
Clinilabs uses technology systems like Veeva Vault and Medrio to support electronic data management, trial master file (eTMF), and clinical trial management system (CTMS) functions, ultimately:
- Optimizing trial execution
- Providing real-time visibility
- Ensuring efficient study data and documentation management
Clinical InSite™
An electronic data and document management tool, Clinical InSite™ holds clinical trial data in a validated, audit-trail environment to simplify and streamline information exchange while reducing file management costs:
- Standardizes data capture and filing conventions
- Obtains data and metadata reports
- Facilitates remote monitoring of clinical trial documents collected at investigator sites
- Controls file sharing with permission-based access
- Allows multiple users to post and view electronic documents and data files, encouraging collaboration
- Supports secure data file transfer, management, and vault storage
- Keeps audit trails complete with user identities, edits, content, and time stamps for all posted or changed documents and/or data files
- Offers a query management tool with a help desk ticketing and reporting system
What Other Clinical Trial Management Services Does Your Trial Need?
Whether you’re looking for site selection support, clinical trial project management, or any other solution, we offer a complete range of clinical trial management services to keep your CNS trial on track from first patient in to last data out.
