The professional staff of CCSA includes PhD-, MD-, MS-, MA-, BS-, and BA-level scientists with academic backgrounds and professional certifications in clinical research, pediatrics, organic chemistry, biochemistry, anatomy, physiology, genetics, carcinogenesis, pharmacology, immunology, toxicology, cell and molecular biology, biostatistics, and computer science.
Our scientists and subject matter experts are responsible for keeping abreast of the scientific literature and provide support in analysis of nonclinical and clinical data, protocol design, and preparation of regulatory documents, study reports, and white papers and manuscripts. Our library staff is skilled at scientific literature retrieval, data extraction, and data mining. Our regulatory affairs staff includes a Certified IRB, RAC Professional as well as Board-certified Toxicologists and other professionals with multiple years’ experience in clinical development planning; regulatory affairs; and preparing regulatory dossiers such as initial INDs, CTAs, NDAs/ANDAs, DMFs, and IDEs. Moreover, we are experts at reviewing protocols and study reports, CRFs, and ICs, supporting regulatory documents such as Form FDA 1572, IRB approvals, laboratory certification, financial disclosure, etc.
Collaborating with each other, and under our clients’ direction, our staff prepares and implements required SOPs and provide necessary training. Our safety staff members include physicians, registered nurses, public health administrators, and certified Clinical Research Associates, each with more than five years of direct experience in clinical research, who have handled SAE evaluation and reporting in the US. They provide support to clients’ medical staff in safety assessment and evaluation of SAEs. Our QA and Compliance team has extensive experience auditing investigational sites, clinical research data, and data systems. They assure compliance with established guidelines and SOPs in accordance with client, ICH, and FDA regulations.
Our IT and informatics staff provide infrastructure support and maintain all the necessary informatics to old and new data managements systems. Our technical administrative team, proficient in word processing and presentation software, will assist to prepare project documents, including guidelines, SOPs, and training materials.