Clinical Trial - Operational and Strategic Services

Full Service Clinical Trial: Strategic expertise, operational integration, and superior partnership. CNS recognizes the value represented by pairing experts in the development of central nervous system therapies with experienced professionals in

clinical trial execution. In part, this is a targeted response to the lack of efficiency in the modern clinical trial development model. By providing scientific expertise with execution capabilities to bring untested potential therapies from first-in-human studies through proof-of-concept within a single organization, CNS offers a unique opportunity to shorten development cycles and reduce costs for testing new compounds. In doing so, CNS provides:

CNS expert input and analysis, critical for clinical development pathway and scenario planning, Phase 1 and 2 results interpretation, and early alternative indication reviews
Turn-key operations to move from first-in-human through proof-of-concept testing in a single, therapeutically-focused organization
Collaborative protocol design and writing, aligned with Critical Path Initiative [FDA]
Dedicated, top-tier project and data management teams, focused on communication and transparency in execution
Academic and scientific exchange across CNS and client groups including discovery and early development teams, as well as biostatistics, data management, and regulatory personnel
Confident answers to Go/No-Go questions raised by ‘failed’ proof-of-concept studies or safety findings in animal toxicology or Phase 1 testing
Primary services provided through core capabilities or partnerships
- Clinical program and protocol development
- Project, site and medical management
- Study execution-clinical conduct
- Data Management and Biostatistics
- Quality Assurance
- Scientific/medical writing and communication

CNS’ Collaborative Centralization

Central Budgeting and Contracting. CNS’ centralized contracting has a strong reputation for efficiency and quality, allowing for quick study start-up of trials. Client convenience is supported by a single point of contact for sponsors through which to contract with multiple CNS centers.

Regulatory (IRB) and Quality (QA) processes. CNS partners with independent Institutional Review Boards. With confidentiality as the overriding objective, sponsor and patient information contained in protocols, investigator brochures, informed consents, and IND safety reports, are safeguarded through locked and restricted access. All reviewed material is confidential. Meeting regularly, Independent IRB (www.iirb.com) is the convenient and responsive choice for studies executed with Comprehensive Phase One; ad hoc sessions can be convened to meet any particular regulatory needs. Approval letters for IRB review items are typically available hours following the meeting. CNS’ Advanced Phase Research centers can use any central IRB, depending on the sponsor’s request, except for inpatient activity at our Northern Virginia center, which works with a local, hospital-based IRB.

CNS maintains strong quality assurance programs and feedback mechanisms. With a comprehensive system for accuracy and compliance to assure quality data delivery, CNS centers adhere to internal Standard Operating Procedures (SOPs) and Clinical Operating Guidelines that meet or exceed FDA regulations, GCP guidelines, and the Sponsor's SOPs and QA programs. Sponsor confidence is supported by quality control reviews, quality assurance audits, regulatory reviews, clinical monitor and auditor training, investigator site audits, and institutionalized disease-state training.

Recruitment strength. CNS supports central recruitment strategies to enable local enrollment success. including message creation, media mix planning and placement, and advertising effectiveness monitoring for mailings, television, radio and the Internet.