Safety

Obtaining an in-depth understanding of a product’s safety profile and processing adverse events across its development lifecycle requires therapeutic area expertise, knowledge of regional regulations, and technological proficiency. ClinChoice’s case processing teams have perspicacity honed by years of analyzing and processing adverse events that are identified in clinical trials. We have proven experience in complying with safety management plans and regulatory requirements to ensure that processed events are submission-worthy and reported on time. Our services include:

• Inbound, tracking, collection, and triage of adverse events
• End-to-end case management including intake, triage, data entry, quality review, medical review, and submissions followed by reconciliations
• Adverse event processing, in the safety database or customization as needed
• Coordinate and obtain the medical review and medical assessment, including, when needed, the analysis of similar events, in cooperation with the medically qualified personnel
• Follow-up on the cases in collaboration with the study sites, including the resolution of all the technical/scientific/medical queries
• Case reconciliation between the safety and clinical databases
• Support for unblinding of studies
• Reporting to health authorities 

Developing an early understanding of the safety profile of investigational drugs plays a significant role in the success of clinical trials. Collating and analyzing relevant articles using search strings that are created using strategic inputs needs experienced teams that have excellent disease expertise and scientific acumen. ClinChoice’s literature monitoring teams provide a comprehensive suite of services to generate trends by observing drug class effects and contributing to signal management.

• 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 authoring of summaries
• Literature protocol and reports
• Targeted literature support to develop a Benefit-Risk Evaluation Framework

Quality, insightful, and compliant safety reports developed by experienced authors through rigorous analysis of adverse events are critical for the progression of clinical trials and obtaining approvals from health authorities. ClinChoice’s medical writers have a distinguished record of developing comprehensive safety reports that broaden the understanding of a product’s safety profile and comply with pharma regulatory affair requirements.

The staff take ownership of aggregate reporting calendars, obtain line listings, perform technical and medical reviews, and support the development of responses to health authority queries. We have extensive experience in the following report types:

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

Identifying potential signals from small datasets requires a deep understanding of therapeutic areas and the ability to choose the right modeling and adjust the data based on the pre-approval clinical phase of product development. ClinChoice has an accomplished signal management team that has worked with quantitative and qualitative methods using different leading tools and techniques to optimize the safety operations of clinical trials by generating critical insights as and when new data becomes available. 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

Generating evidence confirming that the benefits of pre-approved drugs outweigh the risks requires in-depth therapeutic expertise, extensive analytical capabilities, and know-how of regulations. ClinChoice’s expert team of physicians and product specialists collaborate to design and prepare risk mitigation plans (RMPs) and risk evaluation and mitigation strategies (REMS) to support marketing authorization applications to the FDA and EMA.

• 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

ClinChoice’s medical information call centers (MICC) support our clinical trial operations to ensure that engagement with the patient communities, healthcare providers, site staff, and other stakeholders is seamless and complies with regional privacy regulations. Our experienced staff manage inbound and outbound activities using the latest technologies that ensure high operational visibility. We leverage our call center capabilities to expedite recruitment, coordinate with sites, provide appointment reminders, and facilitate remote nurse communication. Our services include:

• Management of call intake, triage, and follow-up
• Documentation of calls and request fulfillment
• Development 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