As medical device manufacturers continuously invent new and cutting-edge solutions for patients and consumers, the need to communicate value with evidence in a highly competitive market has only become more compelling. ClinChoice provides the capabilities to obtain approvals necessary for go-to-market initiatives and educate stakeholders in the healthcare community about the use and benefits of medical devices.
Medical Devices & Diagnostics
Literature Review
ClinChoice’s medical affairs teams provide high-caliber medical and scientific literature review services to generate clinical evidence from published literature supporting clinical evaluation reports, post-marketing surveillance, pre-market approvals, and new product development. Our multi-faceted and accomplished teams are committed to analyzing relevant information and providing important insights that can help with product enhancements, maintain compliance, and educate HCPs and patients.
- Systematic literature review planning and schedule management
- Author and review systematic literature review protocols
- Design and review literature search strategies
- Literature software and database management
- Article screening and appraisal
- Author and review systematic literature review reports
- Support on notified body responses
Post-Marketing Surveillance
The introduction of Post-Marketing Surveillance (PMS) under MDR and IVDR guidelines requires medical device manufacturers to summarize results and conclusions based on consistent, standardized, and systematic reviews of PMS data. ClinChoice’s medical affairs team is well versed in and experienced in authoring PSUR & PMSR reports based on MDR & IVDR Guidelines. Our experience includes:
- Develop PMS plan
- Benefit-risk determination
- Post-marketing clinical and performance follow-ups
- Analysis of vigilance, sales, and device-use data
- Description and rationale of CAPA
- Notified body submission and response support
- EUDAMED publishing
Clinical Evaluation Reports, State-of-the-Art, Summary of Safety and Clinical Performance
The stringent regulations in mature markets have put the onus on medical device manufacturers to update the safety and performance of their products to meet compliance requirements. Despite the existing guideline MEDDEV 2.7/1 rev4 and requirements of the MDD, the introduction of the MDR has revamped what a CER should look like and include, as well as created the requirement for a summary of safety and clinical performance for medical devices. ClinChoice has seasoned medical device experts who adopt a holistic approach to analyzing data from clinical, non-clinical and post-marketing sources for devices across all classes and author first-rate documents that influence product development and enhance patient safety that ensures compliance with stringent regulations for marketing the devices across the globe Additionally, ClinChoice has a sizeable team of physicians with clinical expertise who cover a wide range of medical conditions.
- Complete analysis of risk-benefit that encompasses all available data on the device and similar devices
- Analyze clinical and non-clinical data
- Support across all functional manufacturing teams (including R&D, regulatory, and others)
- Author and review Clinical Evaluation Report (CER), State-of-the-Art Report (SOAR) and Summary of Safety and Clinical Performance (SSCP)
- Conduct gap analysis of existing reports and templates
- Publications development, writing, and review
Health Economics & Market Access
ClinChoice can use its expertise to support the development of epidemiological models and generate evidence for value communication with different stakeholders. Our teams have the necessary skills and technological know-how to enable organizations to create assets that help prepare them for entry into new markets with strategic insights.
- Epidemiology support and bias assessment of clinical or observational studies
- Study protocol development
- Literature review
- Manuscript writing and editing
- Publication support
Scientific Research Evaluation
ClinChoice offers support in the preparation and review of medical writing activities of clinical trial documents and reports. Our team diligently works on evidence review for assigned therapeutic areas and literature scans, searches, and reviews for summaries and reports.
- Assist with the clinical trial documents and reports preparation and review of medical writing activities
- Safety reporting: PBRERs, DSURs, PADERs, SAE death narratives
- Manuscript writing and editing
- Quality review and source data verification
Copy Development & Review
Our staff specializes in providing high-quality copy review services developed by our thorough and expert-driven processes, which reduce approval time and ensure promotion-ready materials that resonate with target audiences and deliver impactful results. ClinChoice provides a delicate balance between maintaining global standards while factoring in local distinctions—a skill that comes with a practice rooted in market intelligence and years of experience.
- Copy Review
- Literature Evaluation
- Claims Verification
- Claims Standardization
- Data Analysis on Basic Biostatistics
- Content Alignment
- Benefit and Risk Information
- Proofreading
Post-Market Clinical Follow-Up (PMCF)
PMCF is a post-market surveillance activity stipulated by the EU MDR designed to continuously gather, assess, and analyze clinical data pertaining to medical devices after it has been placed on the market. ClinChoice’s experienced team collaborates with manufacturers to develop PMCF plans and reports and assist PMCF activities, ensuring compliance with regulatory requirements and efficient support for ongoing product success and safety.
- Source document reviews and gap analysis
- Literature searches and reviews
- Data analysis (registries, databases, user feedback surveys, post-market surveillance documents)
- PMCF plan generation and review
- PMCF evaluation report generation and review
- Document proofreading and quality control
- Safety monitoring and reporting