Safety

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:

• Management of call intake, triage, and follow-up
• Documentation of calls and request fulfillment
• Authoring of first-time-right responses
• Independent quality review of calls
• Creation and maintenance of FAQs
• Product replacement and refund support
• Omnichannel support
• Multilingual support via translation services

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:

• Vigilant monitoring of expedited reporting and timely submission
• Timely and accurate submission of adverse event reports to health authorities
• SUSAR submissions to Sponsor/Medical monitor/IRBs and Ethics Committee
• Coordinate and obtain the medical review and medical assessment in cooperation with medically qualified personnel
• Case reconciliation between the safety and clinical databases
• Support for unblinding of studies
• Reporting to health authorities

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:

• Development Safety Update Reports (DSURs)
• Investigational New Drug (IND) safety reports
• Periodic Safety Update Reports (PSURs)
• Integrated summaries of safety
• Developmental Risk Management Plan

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:

• Signal detection and triage
• Signal validation and evaluation
• Signal analysis and prioritization
• Signal assessment
• Authoring of signal validation reports
• Support for labeling updates

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:

• Creation of search strategies
• Local and global literature monitoring services
• Management of translation and procurement of shortlisted articles
• Joint development of inclusion and exclusion criteria
• Analytical writing for summaries
• Development of literature protocols and reports
• Targeted literature support to develop a benefit-risk evaluation framework

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:

• Safety information reviews and revisions
• All sections of medical assessments
• Full safety profiles
• Risk-related position papers
• Risk-benefit evaluations
• Integrated Summaries of Safety (ISS)
• Product expectedness lists
• Company core safety information development and update