Services
Comprehensive Site Operations Management
At Medisol, we understand the complexities of managing clinical trial sites. Our comprehensive site operations management services are designed to ensure the smooth running of your trials. This includes:
- Protocol Feasibility Assessment: We conduct thorough evaluations to determine the viability of protocols at your site, ensuring alignment with your capabilities and resources.
- Staff Training and Certification: Recognizing the importance of skilled personnel, we provide specialized training and certification programs to enhance the expertise of your staff in clinical trial management.
- Standard Operating Procedure (SOP) Development: Our team assists in developing and implementing SOPs tailored to your site's specific needs, ensuring consistency and compliance with regulatory standards.
- Data Management and Quality Control: We manage data collection, processing, and analysis with the utmost precision, implementing robust quality control measures to maintain the integrity of your trial data.
Strategic Patient Recruitment and Retention
Patient recruitment and retention are critical to the success of clinical trials. Our strategies are designed to:
- Targeted Patient Recruitment: We employ targeted recruitment strategies to identify and engage suitable participants, maximizing enrollment efficiency.
- Optimization of Patient Screening and Enrollment: Our team streamlines the screening and enrollment process, reducing bottlenecks and enhancing participant throughput.
- Retention Programs and Patient Engagement Tools: We develop customized retention programs and utilize innovative engagement tools to maintain participant interest and minimize dropouts.
- Patient Education and Support: Providing comprehensive education and support to patients, ensuring they are well-informed and comfortable throughout the trial.
Rigorous Regulatory Compliance
Navigating the regulatory landscape of clinical trials can be challenging. Medisol offers:
- IRB/EC Submissions and Approvals: We manage all aspects of IRB/EC submissions and approvals, ensuring timely and compliant processes.
- Site Regulatory Document Management: Our team oversees the management of all regulatory documents, maintaining up-to-date and accessible records.
- Audit Preparation and Support: We provide comprehensive support in preparing for audits, ensuring your site is always inspection-ready.
- Adherence to GCP and Regulatory Guidelines: Our commitment to strict adherence to Good Clinical Practice (GCP) and regulatory guidelines ensures the highest standards of compliance.
Efficient Study Start-Up and Close-Out
We streamline the start-up and close-out phases of clinical trials:
- Investigator Site Identification and Selection: Our team assists in identifying and selecting the most suitable sites for your study, ensuring optimal geographic and demographic coverage.
- Contract and Budget Negotiation: We handle contract negotiations and budget management, ensuring favorable terms and efficient resource allocation.
- Investigator Meeting Coordination: Medisol coordinates investigator meetings, facilitating effective communication and collaboration among all stakeholders.
- Study Close-Out Activities and Document Archiving: Our comprehensive close-out procedures ensure all study activities are properly concluded and documents are securely archived for future reference.
Equipment Rental and Calibration Services
Understanding the need for reliable and accurate equipment in clinical trials, we offer:
- High-Quality Equipment Rental: We provide a range of top-quality equipment for rent, ensuring your trial has the necessary tools for success.
- Flexible Rental Durations: Our rental services are flexible, accommodating the varying timelines of different studies.
- Regular Maintenance and Calibration: We ensure all equipment is regularly maintained and calibrated for accuracy and reliability.
- Dedicated Support for Equipment Setup and Troubleshooting: Our team offers full support for equipment setup and addresses any troubleshooting needs promptly.