02 pillar
Clinical Development – Validating Tomorrow’s Solutions
From trials to triumphs, we navigate the path to clinical validation and regulatory approval.
Welcome to our Clinical Development Pillar, a cornerstone of our service offerings, where innovation meets validation. Join us as we navigate the intricate pathways of clinical trials and evidence generation, turning your concepts into real-world solutions. Keep scrolling to unveil the roadmap for your next clinical breakthrough.
Clinical Development Pillar Core Services
- Clinical Evaluation Reports
- Clinical Protocol Development
- Data Integrity & Management
- Post-Market Clinical evaluations
- adverse event analysis
- GCP Compliance
CLINICAL EVALUATION REPORTS
Thorough development of Clinical Evaluation Reports (CERs) to meet regulatory standards and support product claims.
Clinical Evaluation Reports are critical for demonstrating the safety and performance of medical devices. Our comprehensive approach ensures that your CERs meet the stringent requirements of regulatory bodies. We focus on:
- Literature Review: Conducting exhaustive reviews of scientific literature to support the device’s clinical benefits and safety.
- Data Analysis: Analyzing clinical data from various sources to provide robust evidence of device performance.
- Gap Analysis: Identifying and addressing gaps in clinical evidence to ensure regulatory compliance.
- Regulatory Compliance: Ensuring CERs adhere to the latest regulatory guidelines, including MEDDEV 2.7/1 revision 4 and EU MDR.
- Report Writing: Crafting clear, concise, and well-organized reports that effectively communicate clinical findings.
- Stakeholder Review: Facilitating reviews by internal and external stakeholders to validate the report’s content and conclusions.
With our expertise in developing Clinical Evaluation Reports, you can confidently demonstrate the clinical validity and safety of your medical device.
CLINICAL PROTOCOL DEVELOPMENT
Design and optimization of clinical study protocols to meet regulatory and scientific standards.
Clinical protocol development is critical to the success of your studies. We ensure your protocols are scientifically rigorous and meet all regulatory standards. Our focus includes:
- Protocol Design: Crafting detailed study protocols that outline objectives, methodology, and analysis plans.
- Regulatory Alignment: Ensuring protocols meet the requirements of regulatory bodies.
- Feasibility Assessment: Evaluating the practicality of the study design and making necessary adjustments.
- Ethical Considerations: Incorporating ethical guidelines to protect participants’ rights and safety.
- Optimization: Refining protocols to enhance study outcomes and minimize risks.
Our expertise ensures that your clinical protocols provide a solid foundation for successful studies.
DATA MANAGEMENT AND STATISTICAL ANALYSIS
Collection, analysis, and interpretation of clinical data to support regulatory submissions.
Effective data management and statistical analysis are crucial for regulatory submissions. We provide comprehensive services to ensure your data is robust and reliable. We focus on:
- Data Collection: Ensuring accurate and systematic data collection processes.
- Data Quality Assurance: Implementing measures to maintain high data quality.
- Statistical Analysis: Applying advanced statistical methods to analyze data.
- Data Interpretation: Providing clear and meaningful interpretations of statistical results.
- Regulatory Reporting: Preparing data reports that meet regulatory standards and support submissions.
Our services ensure your clinical data supports the safety and efficacy of your medical device.
POST-MARKET CLINICAL STUDIES
Planning and implementation of studies to assess long-term safety and efficacy post-market.
Post-market clinical studies are essential to monitor the performance of your device after it hits the market. Our services include:
- Study Design: Developing post-market study protocols that address long-term safety and efficacy.
- Implementation: Conducting post-market studies to gather real-world data.
- Data Analysis: Analyzing study data to identify trends and outcomes.
- Regulatory Compliance: Ensuring post-market studies meet regulatory requirements.
- Reporting: Preparing detailed reports to inform stakeholders and regulatory bodies.
With our expertise, you can confidently assess and ensure the continued safety and effectiveness of your device.
ADVERSE EVENT ANALYSIS
Comprehensive analysis and management of adverse events to ensure patient safety and regulatory compliance.
Adverse event analysis is crucial for maintaining the safety and efficacy of medical devices. Our thorough approach ensures that all adverse events are accurately identified, analyzed, and managed. We focus on:
- Event Identification: Systematically identifying adverse events through rigorous monitoring and reporting systems.
- Data Collection: Gathering detailed information on adverse events from various sources, including clinical trials, post-market surveillance, and user feedback.
- Root Cause Analysis: Investigating the underlying causes of adverse events to prevent recurrence and improve device safety.
- Regulatory Reporting: Ensuring timely and accurate reporting of adverse events to regulatory authorities, including compliance with FDA and EU MDR requirements.
- Risk Assessment: Evaluating the impact of adverse events on overall device safety and implementing necessary risk mitigation strategies.
- Continuous Improvement: Using adverse event data to drive continuous improvement in product design, manufacturing, and quality processes.
With our expertise in adverse event analysis, you can ensure patient safety and maintain compliance with regulatory standards.
GCP AUDITS AND COMPLIANCE
Audits and assessments to ensure compliance with Good Clinical Practice (GCP) standards and regulatory requirements.
Ensuring compliance with GCP standards is vital for the integrity of your clinical trials. Our audit services include:
- Site Audits: Conducting thorough audits of clinical trial sites to ensure GCP compliance.
- Process Assessments: Evaluating clinical processes and identifying areas for improvement.
- Documentation Review: Reviewing trial documentation for accuracy and completeness.
- Regulatory Guidance: Providing recommendations to align with regulatory standards.
- Corrective Actions: Developing and implementing corrective action plans to address compliance issues.
Our GCP audits and compliance services ensure your clinical trials adhere to the highest ethical and regulatory standards.
Solutions for Every Milestone of Your Journey
Commercializing a medical product is a complex and multifaceted endeavor. At Fission, we’ve developed six Market Access Pillars to support every step of your MedTech venture from concept, to your first sales, and beyond.
If you only need a website designed, quality procedures developed, or a full 510(k) submission, we’ve got you covered.
OUR SERVICES
Market Access Pillars
Design & Development
- Project Management
- Usability Engineering
- Design History File Creation
- Verification & Validation
- Risk Management Planning
Clinical Development
- Clinical Protocol Development
- GCP Compliance
- Clinical Evaluation Reports
- Data Integrity & Management
- Post-Market Clinical Studies
Quality Systems & Compliance
- Quality Management Strategy
- Quality Management Systems
- Mock FDA Inspections
- Regulatory Audit Prep
- Compliance Training
Regulatory Affairs
- Regulatory Strategy
- FDA Submissions Support
- Regulatory Gap Analysis
- Global Submission & Registration
- Regulatory Compliance
Commercialization
- Brand Development
- Strategic Marketing Planning
- Content Strategy & Creation
- Digital Marketing
- Social Media Management
Maintenance
- Post-Market Surveillance
- Continuous Quality Improvement
- Product Lifecycle Management
- Regulatory Reporting
- Complaint Management
At Fission Consulting, we’re not just another consultancy—we’re your dedicated partners in navigating the complexities of the medical device industry. With a team of expert consultants spanning all core service areas, we offer unparalleled expertise and guidance at every stage of your journey, from concept to market dominance.
