For Phase 2-3 CNS Clinical Trials
From developing a common protocol and ensuring data quality and consistency across sites to managing communication and regulatory compliance, multisite studies are inherently intricate — and that’s without the complexities of CNS.
When you need to get your global CNS clinical trial to the next milestone, your pathway to streamlined Phase 2-3 trial management starts with Clinilabs.
Complete Phase 2-3 Trial Solutions
As the CNS CRO, we offer comprehensive trial management services that are grounded in a common vision: bringing your product to the people who need it most.
Clinical Trial Management Services
A CRO for global studies — With global capabilities and experience conducting Phase 2-3 trials in North America, Europe, and Asia Pacific regions, we coordinate your entire multicenter trials in the countries and regulatory environments needed
Clinical project management — Our high-performing project managers ensure effective communication between our project team, investigator site staff, 3rd party vendors, and other stakeholders while addressing issues, sharing information, and maintaining trial momentum. We combine all parties into a single, unified team
Project planning — We develop and implement detailed project plans that include key performance indicators that keep your project on track; efficient planning enables you to meet critical milestones at every step along the way to completion
Site management — We manage each participating site, efficiently guiding recruitment, enrollment, data collection, protocol adherence, and more
Vendor management — Today’s clinical trials often involve multiple 3rd party vendors. We include these vendors as part of our team, simplifying sponsor involvement. Your Clinilabs project manager is your single point of contact for all 3rd party vendor needs
Training and support — Providing adequate training and support to site personnel, we ensure they understand the protocol, use appropriate procedures, and maintain data quality
CNS ratings and placebo response management – We implement strategies to support consistency of investigator ratings and manage placebo response, a common cause of failure in CNS clinical trials
Budget management — You can be confident that we will adhere to the project budget you approved, with timeliness and transparency in reporting project-related expenses; it is a no-surprises approach to cost control
Clinical Trial Data Services
Electronic data capture — Clinilabs utilizes the industry’s leading electronic data capture (EDC) systems to meet the needs of your trial. The systems we employ are user-friendly, minimizing investigator site burden and offering sponsors access to detailed activity reports. Information about study progress is available in real time, keeping all members of your study team on the same page
Electronic source – When appropriate, we implement electronic source data collection to streamline data acquisition at the investigator site level. Key elements such as consent forms, clinical outcomes assessments, and other information may be captured using eSource
Data management — Clinilabs uses the latest in digital technology for the back-end processing of data from multiple investigator sites, ensuring data quality, consistency, and accuracy at every turn
Queries and query resolution — Our CNS-focused clinical research associates monitor electronic data remotely and on-site, making it possible to post and close queries quickly and generate monitoring reports promptly
Core Laboratory — Our seven core laboratories aggregate and centrally process medical device and wearable data from multicenter clinical trials
Advisory & Regulatory Support
Consultation — We employ senior scientists with expertise in the development of neurotherapeutics; these therapeutic area leaders work with our scientific advisors to develop study designs that meet your scientific objectives
Advisory boards — We specialize in assembling groups of subject matter experts and key opinion leaders to orient the direction of your clinical development program
Data safety and monitoring boards — When studies require scrutiny of safety data, we establish DSMBs composed of experienced clinicians who analyze subject safety and welfare as clinical trials progress
IND support — Our experienced medical writers work hand in hand with your team to prepare the clinical elements of IND submissions
Clinical protocols — Our team of CNS experts gives you the ability to develop study elements, study synopses, and clinical trial protocols that meet regulatory standards; precision ensures trial-wide consistency in procedures, data collection, and participant management across all sites
Regulatory compliance — Our global regulatory experts help you navigate complex compliance requirements across different sites and jurisdictions
Clinical Trial Technology and Accelerators
Our cutting-edge technology plays a key role in streamlining processes, enhancing communication, and improving data management in multicenter trials.
Clinical Trial Monitoring
Our clinical trial monitoring services include clinical and medical monitoring to keep your trial on track and your patients well cared for.
Electronic Case Report Forms (eCRFs)
We provide eCRFs on multiple platforms, including Medidata RAVE and Medrio. Working in accordance with CDASH and CDISC standards, we also offer:
- Automated, customized data queries
- Reconciliation of queries, AEs, and SAEs
- Real-time clinical trial metrics and reports
- Prompt delivery of hard-locked database
Biostatistics Services
Our clinical trial data management solutions also include a full portfolio of biostatistics services delivered by a team of advanced statisticians who are experts at:
- Power calculation
- Randomization and blinding
- Statistical analysis plans
- SAS programming
- Production of tables, listings, and figures
- Database integration and integration summary
- Statistical reports
Choose between standardized statistical tables, listings, figures, and reports to help you save time and money or customized services, including statistical programming, to support even the most demanding study requirements.
All clinical trial data are retained at our validated technology center in the United States, and our expertise in the implementation of CDISC standards gives you confidence that data can be submitted to regulatory authorities in a high-quality, defendable format.
Clinical Trial Programming and Database Architecture
Our highly skilled clinical database programmers provide general and SAS programming services to meet your study needs, including:
- Programming plan, user specifications, and database architecture and design
- Coding that is simple and easy to understand
- Program validation
- Flexibility, so you can modify codes or apply templates to new projects or study designs
- Programs that run efficiently on execution
We complete programming at study start and within expected timelines to ensure your data can be processed according to plan.
Technology Supporting Our Clinical Trial Data Management Solutions
Clinilabs uses top electronic data systems like Veeva Vault and Medrio to support everything from eCOA/ePRO and EDC to clinical databases and more.
More Than Phase 2-3 Trial Management
When you partner with Clinilabs for your multicenter trial, you’re putting the A team behind your product.
Our dedicated, collaborative CNS experts work in concert to seamlessly support your study from first patient in to last patient out.
