Clinical Service Excellence
Clinical Trial Management
Mecca boasts partnerships with over 1,000 clinical sites strategically located around the globe. These collaborations ensure a diverse and representative participant pool, allowing for robust and comprehensive clinical trials.
Specializing in Clinical Trial Operations
In clinical preparation, Mecca facilitates seamless contract mediation between sponsors and sites/investigators, ensuring efficient agreement signings on behalf of sponsors. Our services extend to streamlined administration of site payments in various currencies and navigating local regulatory nuances, including familiarity with hospital-specific requirements and authorized personnel. We prioritize meticulous preparation for successful clinical trial execution.
Navigating Clinical Trials
Our comprehensive Clinical Trial Operations cover a spectrum of crucial phases. We meticulously handle feasibility assessments, conducting in-depth analyses of competitive studies and site workloads. Pre-study evaluations ensure optimal site selection, followed by seamless setup and support for investigational sites. From preparing and organizing investigator meetings to overseeing study initiation, monitoring, and managing sites between visits, our expertise ensures smooth operations. Finally, we conduct meticulous close-out visits and facilitate archiving, ensuring every trial phase is meticulously managed for success.
CLINICAL TRIAL SERVICES
Mecca specializes in Clinical Trial Services tailored to meet the unique needs of each study phase. From protocol development and site selection to meticulous data management, analysis, and comprehensive reporting, our services ensure precision and compliance at every stage. With a focus on regulatory adherence and trial success, we provide expert guidance for seamless clinical trial execution.
IRB Supports, Protocols and SOP Development
We assist in IRB approvals, developing comprehensive protocols, and refining Standard Operating Procedures (SOPs). This process ensures ethical compliance, outlines trial procedures, and standardizes operations for consistency and reliability.
Site Selection and Management
Rigorous site selection involves evaluating facilities based on expertise, patient access, and adherence to trial protocols. Once chosen, effective management ensures sites comply with standards, support patient recruitment, and maintain high-quality data collection.
Clinical Monitoring
Our clinical monitoring involves meticulous oversight of trials, ensuring adherence to protocols, patient safety, and data accuracy. Our monitors conduct regular site visits, verify data, and maintain regulatory compliance to uphold trial integrity.
Central Lab and Comparator Selections
Rigorous site selection involves evaluating facilities based on expertise, patient access, and adherence to trial protocols. Once chosen, effective management ensures sites comply with standards, support patient recruitment, and maintain high-quality data collection.
Data Management and Analysis
Our robust data management systems ensure secure, accurate, and compliant handling of trial data. This includes collection, storage, and analysis, employing sophisticated tools to derive meaningful insights and support decision-making.
Clinical Reporting
We provide comprehensive clinical reporting, summarizing trial results, and adherence to regulatory requirements. Our reports elucidate findings, ensuring transparency, and facilitating submission for regulatory approvals or publications, contributing to medical knowledge dissemination.
Mecca
info@meccaconsult.com
+1-9494909809
51 JFK Pkwy,
Short Hills, NJ 07078 USA
We support you with Strategy, QMS, Regulations, Biocompatibility, Medical Writing and Clinical Investigation, EU authorized representative, US Agent.
Mecca is exclusively focused on Regulatory Affairs, Performance Testing and Clinical Evaluation for Medical Devices and IVD.
We support our clients with all questions and aspects regarding RA & QA and offer flexible, full-service solutions.