ClinChoice employs its modular yet comprehensive product safety offerings to monitor consumer safety during the product development phases based on the safety profile of the study product. Our global teams work tirelessly using their domain experience and industry-leading technologies to collect, analyze, and process adverse events quickly and accurately while complying with the safety management plan.
Given the rapid adoption of decentralized clinical trials for consumer healthcare, a medical information call center operation plays a critical role in ensuring the success of clinical trials. ClinChoice’s expert staff helps accelerate recruitment, maintain continuous engagement with patients throughout the trial, and aid seamless coordination between stakeholders to improve retention. Our services include:
Expert case processing operations are an indispensable part of a high-quality clinical trial. The collection, accurate analysis, and timely processing of adverse events from clinical trials by medically and scientifically qualified staff contribute to the development of a holistic understanding of the safety profile of molecules. ClinChoice provides a highly trained staff who have strong regulatory knowledge and are adept in using the leading safety databases. Our services include:
Exceptional safety reports and contributions to safety sections of regulatory submission documents need the involvement of authors and reviewers who have proven experience in therapeutic areas, regional regulations, and technologies. ClinChoice’s medical writers author and submit high-quality reports using a combination of dependable project management and competent data analysis to provide an additional layer of insight into the product’s safety profile.
The staff oversees the aggregate reporting calendar management, sources line listings, conducts technical and medical reviews, and responds to health authority queries. We have extensive experience in the following report types:
ClinChoice’s signal management team has proven experience using different models and tools to analyze safety data from clinical trials to be informed about potential risks and the developing safety profile of the product. Our capabilities contribute to every part of the signal management process that develops insight and refines the continuous benefit-risk analysis of the investigational product. Our services include:
Identifying new safety information to contribute to the benefit-risk assessment through the product’s development phases requires a well-thought-out literature monitoring operation. ClinChoice’s staff have comprehensive therapeutic area expertise. They’re experienced in using different technologies to manage literature monitoring operations and contribute to upstream clinical safety functions such as medical writing and signal management. Our services include:
ClinChoice’s safety operations provide thorough risk evaluation and mitigation services that are driven by robust therapeutic experience, exceptional analytical competence, and regulatory insights. Our team of physicians and product specialists have a prodigious ability to develop well-informed risk mitigation plans (RMPs) and risk evaluation and mitigation strategies (REMS) to support approvals for applications. Our expertise includes: