From start to finish... our wide-ranging scientific support services include:
PROTOCOL DEVELOPMENT
TRANSLATIONAL AND CLINICAL SCIENCE EXPERTISE
DATA REPORTING
PUBLICATIONS

Protocol Development
Clinical Research Scientists with extensive experience in translational research and clinical trials methodologies provide consultation and advice to Sponsors for diverse needs, such as:

• Review of pre-clinical and preliminary clinical data
• Assisting the Sponsor in data interpretation to optimize study design
• Developing research methodologies designed to answer study objectives
• Interactive discussions with Sponsor's discovery and early development teams
• Strategies to obtain maximal PK and PD data from a given study
• Maximizing Sponsor investment by delivering appropriate subjects and/or patients, clean data, and on-time completion of the study
• Adherance to stringent internal Clinical Operating Guidelines that meet or exceed FDA regulations, GCP guidelines, and the Sponsor's Standard Operating Procedures

Back to top

Translational and Clinical Science Expertise
In consultation with Sponsors, we have provided significant design input into several Phase I studies including schizophrenia MTD bridging studies. CCT specializes in assisting the Sponsor to address pre-clinical safety issues or recover from a 'failed' Phase II trial. By partnering with the Sponsor, CCT designs and runs a protocol that either gets the drug development plan on track or provides the basis for ending the development program with confidence.

Current research design and consultation activities include:

• Landmark two-part protocol design to evaluate a novel CRF-1 antagonist
• Healthy volunteers and patients with depression and anxiety undergo intensive PSG and CSF dynabridge sampling, first in a drug-free state, then separately whereupon a repeat population will receive the novel compound dosed to steady-state, and subsequently undergo all pharmacodynamic evaluations
• Incorporation of Sleep-PSG into maximum tolerated dose Phase I trials of novel therapies for obesity, to rigorously test possible CNS adverse effects such as disruptions in sleep physiology
• Designing and conducting ethnic sensitivity studies to streamline and accelerate global timelines for drug-development
• Combining novel research tools and techniques into a single comprehensive proof of principle study. Includes measurement of changes in anti-apoptotic proteins, i.e., BDNF, and bcl-2, in CSF as a function of various drug dosages and dosing regimens of an 'ampakine'
• Protocol design and writing in areas that require specialized expertise to address drug development "stumbling blocks."We collaborate with a wide array of academic and private sector colleagues with diverse and unique capabilities to add value for Sponsors

Back to top

Data Reporting
CCT can tabulate and perform basic statistical tests on collected Phase I data, especially in regards to adverse events. These data tables are an essential component of the frequent conference calls between a Sponsor and CCT, when a go/no-go decision on dose escalation needs to be made.

With extensive experience working with the FDA, CCT can assist you with:

• Generating or editing study reports
• Providing consultation with FDA-related filings and data reporting
• Assisting in identifying data gaps and design studies needed to support the drug approval process and label
• Providing assistance with the filing of an IND

Back to top

Publications
Our investigators serve on Journal Editorial Boards as manuscript reviewers and program chairs to evaluate abstracts submitted for presentation. Their experience includes consulting and grant reviewering to the NIH and other organizations.

CCT can assist you with:

• Publication and presentation strategies
• Recommendations for the most suitable journals for publication
• Professional and scientific meeting suggestions best suited to the content and scope of the project
• Writing the manuscript, or editing a science writer's draft
• Employing novel statistical approaches for data analyses

Full CRO Services

Biostatistics/analytics
Clinical Trials
Clinical Pharmacology
Contract Personnel
Data Management
Strategy Development
Health Policy & Strategic Reimbursement
Medical Communication Services
Medical Services
Medical Writing
Peri Approval Services
Pharmacovigilance
Site Services

Back to top