Strategic Planning
CCSA has a strong record of providing consulting services on strategies for drug development.
Regulatory Affairs
Our team of toxicologists, chemists, pharmacologists, and regulatory affairs professionals work closely to move projects from conception to approval.
Early Development
Board-certified toxicologists, pharmacologists, chemists, biochemists, microbiologists, nutritionists, and other scientists with extensive experience in nonclinical research and development make it possible to meet project timelines and goals.
Clinical Trials
CCSA has wide-ranging experience managing and maintaining all regulatory documentation on behalf of sponsors during the complete study lifecycle.
Bioinformatics
CCSA’s Bioinformatics and Data Management departments work together to provide high-quality, cost-efficient solutions for all of our projects.
Pharmacovigilance
CCSA provides meticulous pharmacovigilance to maintain the safety essential for successful clinical trials.
Scientific and Medical Writing
Our scientists and medical writers bring extensive scientific research, writing, and editing skills to preparing materials in support of client programs.
Library Services
CCSA’s library provides a comprehensive approach to scientific literature searches using a variety of bibliographic databases as well as information from the Internet.
eCTD
eCTD is the electronic transfer of information to regulatory agencies based on the Common Technical Document (CTD) format. eCTD utilizes PDF documents linked via an XML backbone.
Our quality and risk management philosophy emphasizes open and frequent communication with all project team members so that requirements are clearly understood, changes are noted, challenges are addressed, and plans are executed to produce the best possible outcome.
