Your Contract Research Organization (CRO) for Clinical Success

A well-structured clinical trial starts with a strategic plan. At Comac Medical, we ensure every stage of your trial is meticulously designed for efficiency, compliance, and success. Our expertise includes:

• Comprehensive Clinical Development Plans – Tailored roadmaps covering all trial phases, ensuring seamless execution from concept to completion.
• Scientific Advice Meetings Preparation – Assistance in organizing and presenting study designs to regulatory authorities. Guidance on addressing regulatory concerns for a smoother approval process.
• Regulatory Guidance & Compliance – In-depth review of evolving regulatory frameworks to keep your trial aligned with current expectations. Expert advice on navigating regulatory challenges across multiple regions.
• Statistics & Methodology Optimization – Development of robust statistical methodologies for study design. Support in addressing regulatory queries related to statistical analysis and data interpretation.
• Market Authorization Support – Assistance with compiling and submitting regulatory dossiers. Ensuring compliance with regional and international regulatory requirements.

With 27+ years of experience and a global presence, Comac Medical is your trusted partner in designing clinical trials that lead to market success. 

Efficient project execution is the cornerstone of clinical trial success. We offer expert project management services that ensure every detail is meticulously coordinated, resources are optimized, and risks are proactively managed for smooth trial progression. Our services include:

• Strategic Project Management Plans – Customized roadmaps that outline key trial milestones, resource allocation, and execution strategies for streamlined study progression.
• Enrollment Target Achievement – Proactive recruitment strategies and continuous monitoring to meet enrollment goals while maintaining patient diversity and retention.
• Clinical Study Oversight – End-to-end supervision of trial execution, ensuring adherence to protocols, regulatory compliance, and quality standards.
• Risk Management & Mitigation – Early identification of potential risks with rapid response strategies to prevent delays and ensure study continuity.
• Seamless Team Communication – Strong collaboration between sponsors, investigators, and research teams to maintain alignment and efficiency throughout the trial.
• Timely Milestone Delivery – Robust tracking systems and performance metrics to ensure projects stay on schedule and within budget.

A successful clinical trial begins with a thorough global feasibility assessment. We excel in identifying the right strategy, selecting optimal sites, and ensuring access to the recruitable patient population, all while navigating regulatory and logistical complexities. We offer:

• Regulatory Environment Analysis – In-depth review of regulatory requirements and approval timelines in different countries to ensure compliance and efficient trial initiation.
• Patient Population Exploration – Assessment of the availability and suitability of the target patient population across multiple regions to maximize recruitment potential and trial success.
• Site Infrastructure & Capabilities – Evaluation of site readiness, including investigator qualifications, available facilities, and experienced staff to ensure trials are conducted with precision and efficiency.
• Logistics & Supply Chain Management – Strategic planning for the distribution of investigational products, handling of biological samples, and overall logistics coordination to streamline trial execution across diverse geographic locations.
• Cultural & Ethical Considerations – Understanding of regional cultural and ethical factors to ensure that the trial meets local norms and practices while maintaining global standards.
• Cost Analysis & Healthcare Standards – Assessment of local healthcare infrastructures, cost factors, and potential challenges in recruitment and study implementation to inform decision-making.

At Comac Medical, we excel in ensuring the integrity and success of your clinical trial through comprehensive monitoring services. Our team is dedicated to maintaining high standards of quality, protocol adherence, and data integrity. Our expertise include:

• Expert Site Support & Investigator Training – We assist with site identification, selection, and conduct pre-study visits, either on-site or remotely. We also provide thorough training to investigational site staff to ensure full understanding and compliance with the study protocol.
• Patient Rights, Safety & Data Integrity – Rigorous monitoring to protect the rights and well-being of trial participants, addressing safety concerns and ensuring ethical standards. We confirm the integrity and accuracy of trial data, ensuring alignment with protocol and regulatory standards.
• Informed Consent & Regulatory Submissions – We ensure the informed consent process is handled accurately, including translation and verification, and timely preparation and submission of regulatory documents, including ethics and review board submissions, to maintain full compliance.
• Material Management & Reporting – Overseeing the warehousing of pharmaceuticals and managing trial-related materials. Our team ensures consistent, comprehensive reporting of trial progress, including any protocol deviations.
• Proactive Risk Management & Ongoing Support – Our team identifies potential risks early, taking proactive steps to address them. We maintain open communication with stakeholders throughout the process for a smooth and efficient monitoring experience.

At Comac Medical, patient safety is our top priority. Our team of experienced medical monitors ensures the safety and well-being of clinical trial participants through real-time data review, proactive risk management, and ongoing support to study sites. Our services include:

• Comprehensive Safety Monitoring & Risk Mitigation – Our medical monitors provide in-depth analysis of patient clinical data, including medical coding, lab values, and protocol deviations, ensuring early identification of any safety concerns or risks. We ensure that any deviations are assessed for their significance and reportability, mitigating potential risks before they escalate.
• Expert Guidance & Training for Operational Teams – We provide specialized therapeutic training for operational teams, empowering them with the knowledge necessary to manage safety concerns and patient care throughout the study. Our medical experts are available to answer inquiries from study sites, principal investigators (PIs), and team members, fostering smooth communication and addressing any challenges that arise during the trial.
• Medical Review & Protocol Compliance – Our team conducts thorough medical reviews of tables, figures, listings, and patient narratives to ensure protocol compliance and data accuracy. We support your trial with expert insights into the clinical implications of safety data, ensuring full regulatory alignment and smooth progression.
• Proactive, Real-Time Support – We offer continuous medical oversight throughout the trial, ensuring ongoing risk management and addressing any urgent safety concerns as they arise. Our experts provide timely guidance on safety trends, patient care coordination, and overall trial integrity.

A successful clinical trial requires a well-defined regulatory strategy. We excel in guiding sponsors through complex regulatory frameworks, ensuring compliance, timely approvals, and seamless submissions. Our expertise ensures that your trial progresses smoothly while adhering to the latest global regulatory standards. We offer:

• Regulatory Strategy Development – Tailored regulatory pathways designed to align with your study’s specific needs and global compliance requirements.
• Regulatory Submissions & Documentation – Preparation, review, and submission of regulatory applications with meticulous attention to detail.
• Communication with Ethics Committees & Regulatory Authorities – Ongoing interactions with ECs and RAs to facilitate efficient approvals and compliance.
• Regulatory Intelligence & Compliance Monitoring – Continuous tracking of evolving regulations to ensure your trial remains compliant with current industry standards.
• Risk Mitigation & Regulatory Support – Proactive identification of potential regulatory hurdles with strategic solutions to prevent delays.

With Comac Medical’s regulatory expertise, you gain a dedicated partner committed to ensuring your clinical trial meets all regulatory requirements, paving the way for a successful study.

Ensuring the integrity and reliability of your clinical trial requires a strong quality assurance framework. At Comac Medical, we implement rigorous quality systems, conduct in-depth audits, and proactively manage risks to maintain the highest standards throughout your study. Our expertise guarantees data accuracy, regulatory adherence, and overall trial excellence. We offer:

• Comprehensive Audits & Inspections – Systematic evaluations of investigator sites, vendors, internal processes, and study-related procedures to ensure full compliance.
• Regulatory Compliance & GxP Training – Preparation for regulatory inspections, guidance on GxP requirements, and training programs to uphold industry standards.
• Quality Event Management & CAPA – Proactive identification, investigation, and resolution of quality issues with effective corrective and preventive actions.
• Document Control & Oversight – Centralized management of essential documents to maintain accuracy, security, and regulatory compliance.

With Comac Medical’s quality assurance expertise, your trial is safeguarded by robust compliance frameworks, ensuring smooth execution, regulatory success, and reliable study outcomes.

Reliable clinical trial outcomes depend on the accuracy and integrity of your data. At Comac Medical, we implement robust data management solutions to ensure precise collection, validation, and analysis, meeting the highest regulatory standards. Our tailored approach streamlines processes, minimizes risks, and accelerates trial timelines. Our services include:

• Custom CRF & EDC Design – Development of case report forms (CRFs) and electronic data capture (EDC) solutions tailored to study needs.
• Data Cleaning & Query Resolution – Rigorous data validation, discrepancy management, and quality control for accurate reporting.
• Database Management & Standardization – Set-up and configuration of databases using CDASH, SDTM, and custom libraries to meet industry and regulatory requirements.
• Clinical Coding & Listings Review – Standardized coding using industry dictionaries and in-depth medical reviews for data consistency.
• External Data Reconciliation – Integration and harmonization of multiple data sources to ensure completeness and accuracy.

With Comac Medical’s expertise, your clinical trial data is managed with precision and compliance, providing a strong foundation for regulatory success.

Ensuring drug safety throughout the clinical trial and post-marketing phases is essential for regulatory compliance and patient protection. At Comac Medical, our pharmacovigilance experts provide comprehensive safety monitoring, risk assessment, and regulatory reporting to support your product’s entire lifecycle. We offer:

• Clinical Trial Safety Management – Full case processing, safety management agreements (SMA), and periodic reporting (DSUR, line listings).
• Post-Marketing Safety Support – Literature searches, product complaint management, and maintenance of Pharmacovigilance System Master Files (PSMF).
• Risk & Crisis Management – Development of risk management plans (RMP) and crisis response strategies.
• Regulatory Compliance & Reporting – Qualified Person for Pharmacovigilance (QPPV) services, global safety database hosting (EudraVigilance), and aggregate periodic reporting (PSUR).
• Global Regulatory Interaction – Coordination with health authorities and submission of CIOMS reports and XEVMPD data.

With a proactive approach to safety and pharmacovigilance, Comac Medical helps you maintain compliance, mitigate risks, and uphold the highest safety standards.