Medical Writing Services

Our Medical Affairs and Writing professionals specialize in providing scientific expertise to the medical community. We provide contract services and support our clients in three distinct areas: medical affairs, medical information / pharmacovigilance, and medical services.

Medical Device Documentation

Clinical Evaluation in CER & CEP Writing Services

ICG offers professional CER & CEP writing services for US, EU, and UK market access.

Our international team of over 100 subject matter experts specializes in handling large projects, delivering multiple Clinical Evaluation Reports & Plans simultaneously.

• Compliance: CERs crafted to meet US, EU, and UK MDR regulations
• Versatility: Suitable for all classes of medical devices across various clinical fields
• Expertise: Fully insured consultants registered with ISO & TOPRA
• Comprehensive Services: MedDev 2.7/1 rev 4, MDD & MDR compliant CER writing
• Qualified Signatories: Appropriate credentials for CER signatories
• Scalability: Capacity to support a global client base, from start-ups to multinational corporations

Comprehensive CER Writing Service for All Device Types & Classes

Our team of expert, medically trained CER writers provides unmatched clinical evidence appraisal and analysis for your medical device clinical evaluations.

• New Reports: Development of new Clinical Evaluation Reports & Plans
• Updates: Revisions and updates to existing CERs & CEPs
• Reviews: Evaluation and review of current Clinical Evaluations
• Support: Literature search protocols and company reviews to support CER creation
• Compliance: Addressing Non-Conformity Reports (NCRs)
• Efficiency: Effective management of tight deadlines and re-submissions

Dedicated CER Specialists

Our dedicated CER specialists ensure your medical devices are compliant, maintaining clear and transparent communication throughout the process.

• Quick Quotes: Fixed prices with no hidden fees
• Fixed Timelines: Commitment to meet your deadlines
• Dedicated Team: Designated project team and primary contact
• Transparency: Continuous and direct visibility of project progress
• Client Satisfaction: No final payments until complete client satisfaction
• Ongoing Support: Continued assistance after CER submission to the Notified Body at no extra cost

Literature Search & Review: Search Protocols & Reviews

Effective Literature Search Protocols & Reviews as the Core of a Compliant Regulatory Strategy

Our international team of over 100 medically trained subject matter experts leverages their clinical expertise to enhance your medical device literature search and company reviews.

• Clinical Insights: Clinical insights and subject matter expertise
• Evidence Appraisal: Evidence appraisal and analysis by professional clinicians
• Objectivity: Experienced objectivity and independent reviews
• Compliance: Adherence to MedDev 2.7/1 rev 4, MDD & MDR standards
• Oversight: Direct oversight of project progress by an assigned lead writer
• Expert Consultants: Fully insured consultants registered with ISO & TOPRA

Specialized Literature Search Protocols for US, EU & UK MDR

Each project is led by TOPRA-registered regulatory professionals managing teams of medical reviewers with clinical experience relevant to the subject device.

• Comprehensive Reviews: Literature reviews for company assessment, clinical evaluations, adverse event characterization, competitor analysis, and various other applications
• Source Management: Sources organized based on inclusion criteria with detailed tracking and reasons for exclusion
• Systematic Analysis: Systematic appraisal and analysis
• Safety Assessment: Assessment of safety and performance criteria using company data
• Context Evaluation: Evaluation of clinical context and background
• Outcome Determination: Determination of outcomes concerning the frequency and severity of harms

Our Guarantees

We ensure comprehensive literature searches and reviews tailored to your objectives, conducted by subject matter experts.

• Customized Quotes: Fast and customized quotes with fixed prices and no hidden fees
• Established Timelines: Commitment to meet your deadlines with set timelines
• Transparency: Full access and transparency throughout the project plan and process
• Tailored Service: Service precisely tailored to meet your specific needs
• Client Satisfaction: No final payments required until complete client satisfaction is achieved
• Ongoing Support: Unlimited and complimentary support during the Notified Body review process

Post-Market Clinical Follow-up: Designing and Managing PMCF Studies

Post-Market Clinical Follow-up (PMCF) is Essential for Medical Devices and Has Never Been More Critical

Company Systems provides a comprehensive and customizable PMCF service, supporting you every step of the way.

• Customized Design: Tailored PMCF system design and implementation specifically for your medical device
• Comprehensive Planning: Crafting PMCF plans, study protocols, investigator brochures, and more
• Data Management: Data collection and storage compliant with GDPR, utilizing ISO-certified EDC systems
• Site Coordination: Facilitating study site onboarding and coordinating with ethics committees
• Adverse Events Management: Handling and management of adverse events
• Data Analysis: Conducting data analysis and producing PMCF Evaluation Reports
• Ongoing Maintenance: Continuous study upkeep and site management

Efficient Implementation of PMCF Design

Our international network of over 50 clinically-active medical professionals drives investigator engagement, ensuring ongoing compliant data collection.

• Expert Insights: Valuable insights on company design from experienced clinical investigators
• User-Friendly Systems: Study processes and systems tailored for optimal end-user usability
• Streamlined Onboarding: Streamlined onboarding for swift approvals and implementation
• Real-Time Tracking: Real-time performance tracking and management of protocol violations
• Clinician Support: Direct support from clinician to clinician
• System Integration: Seamless integration with Risk Management and Quality Management Systems

Our Guarantees

We guarantee optimized PMCF systems that receive rapid approval from investigators, providing a seamless and transparent collaboration experience.

• Transparent Pricing: Tailored quotes with set prices and no hidden extras
• Fixed Timelines: Commitment to meet your deadlines
• Dedicated Team: Allocated project team and named primary contact
• Project Visibility: Direct access and transparency of project progress
• Client Satisfaction: No final payments until client satisfaction
• Ongoing Support: Unlimited and free assistance with notified body review

Medical Information/Pharmacovigilance

ICG’s team of trained healthcare professionals is adept at handling medical inquiries, including reporting of adverse events, product related medical inquires, and product complaints.

Our Medical Information Services (MIS) team works with our clients to create standard responses and frequently asked questions (FAQ) documents based upon internal and client standard operating procedures (SOPs) and processes. As appropriate, our MIS professionals will also fulfill literature requests. Medical Information specialists can create and update standard responses and SOPs as well as identify new topics and develop customized responses.

Specific to our Pharmacovigilance services, we also provide a broad range of adverse event and product complaint support from MedWatch form completion to activities such as narratives, summary reports, physician follow-up, patient contacts, and preparation of annual adverse event reports. All adverse events and product complaints, regardless of serious or non-serious classification, are submitted to clients in a timely manner. Expedited reports are submitted within one business day.

ICG maintains a comprehensive, detailed database and incorporates all call details into this database, seamlessly operating as the company’s Medical Affairs Department.

Medical Services

ICG also provides its clients with project support including medical writing, medical meeting support and field training services. Medical writing may include abstract, poster, and SOP development. Medical meeting support encompasses utilizing one or more of ICG’s healthcare professionals on a per diem basis supporting activities such as MIS support at a scientific booth during a medical conference.

Medical Writing

ICG provides medical writing services that cover scientific, nonclinical, and clinical (phase 1-4) research activities. ICG’s medical writing team is highly skilled with scientific and/or medical backgrounds and experience in industry within multiple therapeutic areas.