Leading-edge scientific services in product discovery and development

(Pharmaceuticals, Biologics and Immunotherapeutics, and Devices)

 

Using OpenClinica as a Safety Data Management System

 

CCSA Support for I-SPY COVID-19 Trial

CCS Associates to Provide Regulatory and Safety Support for I-SPY COVID-19 Trial

 

Healthy Eating

Spotlight on Tomatoes: Fettuccelle con Melanzana Rustica (Pasta with Eggplant Peasant Style)

 

CCSA Makes CIO Applications 2020 Top Ten

CCS Associates, Inc. (CCSA) is a small business providing leading-edge scientific services in product discovery and development to government agencies and the pharmaceutical and biotech industries.

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 works closely with clients 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’s clinical trial monitoring teams provide reliable expertise, exceeding our sponsor’s study timelines and high data quality standards.

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 biomedical literature searches and is a member of NLM’s DOCLINE.

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.