Founded in 1985, CCSA works toward drug development and on other life sciences data related activities. In addition, the firm organizes public and internal datasets from various sources and unifies the data for effective search and analysis. Being an established consultancy firm, “we have several years of experience working on large government initiatives which are geared to make the drug development process more efficient and help improve the quality of patient care,” affirms Dr. Caroline Sigman, President & CEO, CCSA. “We are glad to have also worked on several public-private collaborative projects that involved precision medicine initiatives,” she adds.
CCSA is adept at providing efficient services in clinical trial management, bioinformatics, and regulatory affairs to users for identifying clinical data and maintaining all regulatory documentation on behalf of clients during the complete study lifecycles.“We provide a collaborative approach and our team of clinical research scientists, toxicologists, chemists, pharmacologists, clinical operations experts, data management experts, and certified regulatory affairs professionals works closely to move user projects from conception to approval,” states Caroline. In addition, with its clinical trial and regulatory affairs management services, CCSA helps many small pharma companies move their initial product development programs forward. Through these activities, as well as both on-site and off-site data monitoring services for clinical data, CCSA helps companies accomplish their goals.
In all our activities, from identifying and managing clinical sites to protocol development to producing regulatory submissions we strive to use the best science and technology
“In all our activities, from identifying and managing clinical sites to protocol development to producing regulatory submissions we strive to use the best science and technology,” affirms Caroline. For example, CCSA has adopted the electronic Common Technical Document (eCTD) format for regulatory submissions such as the Investigational New Drug (IND) application. The firm also leads in designing clinical trials and delivering databases and services nationally.
Having more than 30 years of experience and many client success stories to stand as a testament to their prowess, Caroline touches upon a case study, which involved building a clinical database system in Latin America. Due to not having appropriate infrastructure, the client faced problems in developing this system in six different countries and managing their data and workflow. CCSA subsequently designed in just a few weeks a system and network that allowed each country to have its own independent data while also enabling effortless collaboration. “We offered the software in three different languages and the system collected clinical, epidemiology, and DNA testing data as well as provided a method for tracking samples of tissue and blood that would be evaluated in studies done in the network,” affirms Caroline.
Moving ahead, CCSA’s vision is to develop new technologies for clinical trials. “We are very passionate to help our clients and in the near future we want to learn, promote, and plan advanced technologies to make and deliver effective and superior solutions,” concludes Caroline.