Caroline Sigman, President, CEO, CCS Associates
Caroline Sigman, President, CEODue to the effects of the coronavirus pandemic on human life, the World Health Organization developed an R&D blueprint as part of a global strategy and preparedness plan. The aim is to accelerate research into potential treatments for the novel coronavirus and facilitate transparency of information between countries regarding essential drugs and vaccines. However, companies in the life sciences industry find it challenging to navigate past the rough shores toward efficient drug manufacturing processes due to the various protocols and regulations. This mandate extends through regulatory agencies and drugs for other indications world-wide.

A regulatory service provider, CCS Associates, offers services to guarantee the efficiency of the drug development process. It provides a wide range of services, including technical and support services for clinical research, preclinical study design strategies, chemical information sciences, and R&D support. The firm has made significant contributions to bioinformatics, created master databases of chemical data, and collaborated with clients in the public and private sectors to use nonclinical and clinical data to develop pharmaceuticals.

Before becoming a regulatory contractor, CCSA wrote dossiers and chemical and drug evaluation documents for a small group of specialists at the National Cancer Institute (NCI). After establishing itself as an R&D service company, it developed a drug development regulatory program along with NCI, and since 1995, has continued to be in the NCI regulatory service sector for cancer prevention.

CCS Associates: Active Research and Development Strategies for the Pharma World

“As part of a consortium foundation comprised of government and pharmaceutical representatives, CCSA has worked with the government, specifically the FDA and the NIH, to develop standards for testing protocols,” says Caroline Sigman, President and CEO of CCSA.

A leading provider of drug regulatory services, CCS Associates aims to efficiently guide clients through the drug development process. Through standardized regulatory resources, it provides clients with additional assistance to manage, process, and report clinical research data. Clients with less expertise in the pharmaceutical industry benefit from CCSA’s gap analysis, which determines the available data, the kinds of efficacy and toxicity tests needed, and toxicity levels permitted for clinical trials. The firm also assists clients with obtaining FDA approval for investigational new drugs (INDs) by creating and submitting the relevant documentation to regulatory bodies as part of its marketing application services.

As part of a consortium foundation comprised of government and pharmaceutical representatives, CCSA has worked with the government, specifically the FDA and the NIH, to develop standards for testing protocols

The proliferation of new technologies in clinical research, particularly genomic profiling, has led to an influx of data. Due to this, isolating data relevant to product development has become increasingly challenging. Data analysis services provided by CCSA are specifically designed to effectively address data sorting and further drug development. Providing consultation on drug development strategies is a critical component of CCSA’s regulatory services. In collaborative programs with the National Heart, Lung, and Blood Institute (NHLBI), neurosciences groups at NIH, and the National Center for Advancing Translational Science (NCATS), it helped conceive decision plans for drug development. CCSA also helps clients implement technology that aligns with modern standards for clinical trials, like biomarkers based on AI. An active member of various national and industry-level committees, CCSA works to improve the current standards of assay testing.

CCSA’s regulatory services are designed to complement the entire R&D process from start to finish. The regulatory service company is committed to serving the life science research sector with unrivaled scientific and strategic support to facilitate the commercialization of diagnostic, preventative, and therapeutic medical products for the benefit of humanity.