SMO Services

At IRN Comac Medical, we have our unique study delivery model to support Sponsors and CROs, and we pride ourselves on offering comprehensive solutions designed to optimize every aspect of your clinical trial journey.

Here’s how our specialized approach can benefit your trials:

• Provision of Independent Teams: We provide dedicated teams of coordinators and nurses who are fully trained to manage every aspect of your trial, ensuring seamless execution from start to finish.
• Patient Recruitment & Engagement Support: Our expertise extends to patient recruitment and engagement strategies, maximizing enrollment and retention rates for successful trial outcomes.
• Development of Retention and Compliance Tools: We offer innovative tools and strategies to enhance patient retention and compliance throughout the duration of your trial, minimizing dropout rates and ensuring data integrity.
• Site Training: We provide comprehensive training for site staff, both initially and ongoing, to ensure adherence to protocol requirements and regulatory standards.
• Clinical Supply Activities: Our services include managing clinical supply activities and resolving any issues that may arise, ensuring timely delivery of study materials to sites.
• Data Entry and Quality Control: We handle data entry tasks, including CRF/EDC/IRT, with a focus on maintaining high-quality data and compliance with regulatory guidelines.
• Project Activity Scheduling: We manage project activities efficiently, optimizing timelines and resources to meet your trial objectives.
• Patient Recruitment Services: Our dedicated team specializes in patient recruitment, employing targeted strategies to identify and enroll suitable participants for your trial.
• Patient Education: We prioritize patient education, providing resources and support to ensure participants are well-informed and engaged throughout their involvement in the trial.

With our comprehensive suite of services, we stand as your trusted partner for successful clinical trial management. Contact us today to learn more about how we can support your next trial and drive impactful results.

At IRN Comac Medical, we understand the critical role that patient recruitment plays in the success of clinical trials, and we’re committed to helping you achieve your recruitment goals efficiently and effectively. We prioritize a patient-centric approach to ensure faster trial timelines, accelerated recruitment, and sustained patient engagement throughout the study duration.

Here’s how we make it happen:

• Initial Review and Subject Pre-selection: Our trained Clinical Site Managers and Site Coordinators conduct an initial review of patient pools and pre-select suitable subjects, ensuring targeted recruitment efforts from the outset.
• Continuous Database Review: We regularly review databases for newly diagnosed patients, allowing for proactive identification and recruitment of eligible participants.
• Building Referral Physician Network: We assist in building a referral physician network, facilitating the targeting of patients with the same indication from centers not involved in the study to your institution, thus expanding the pool of potential participants.
• Subject Visit Scheduling: Our team manages subject visit scheduling, ensuring seamless coordination and minimizing delays in the recruitment process.
• Dedicated Patient Engagement & Recruitment Team: We have a dedicated team focused on patient engagement and recruitment, implementing fully-integrated campaigns tailored to your study’s specific requirements.
• Physician Practice Outreach: We engage in outreach to physician practices, fostering relationships and facilitating patient referrals to enhance recruitment efforts.
• Protocol Break-down Review: We conduct a thorough review of the study protocol, identifying potential pitfalls and challenges for patient recruitment and quality management at the site level, and develop strategies to overcome them.
• Development of Retention and Compliance Tools: We develop tools and strategies to enhance patient retention and compliance, ensuring participants remain engaged and committed throughout the study.

Our international site management department is dedicated to ensuring the success of your trials by providing tailored support and oversight throughout the process.

Here’s how we make it happen:

• Timely Recruitment Delivery: We ensure timely recruitment delivery per site and per country, optimizing enrollment timelines and maximizing site performance.
• Key Contact with Clinical Site Teams: Our CSMs serve as the primary points of contact for clinical site teams, CROs, and Sponsors, facilitating communication and collaboration to streamline operations.
• Thorough Project Oversight: We provide thorough project oversight on the site support level, monitoring progress and addressing any issues promptly to keep your trial on track.
• Risk Management and Issue Escalation: We employ proactive risk management strategies and facilitate issue escalation processes to mitigate risks and minimize disruptions to your trial.
• Regular Site Support & Augmentation Team Meetings: We conduct regular meetings with site support and augmentation teams to ensure alignment and address any challenges proactively.
• Training: Our site augmentation support team offers comprehensive training to site staff, ensuring adherence to protocol requirements and regulatory standards.
• Quality Oversight at Site Level: We maintain rigorous quality oversight at the site level, implementing measures to uphold data integrity and compliance with regulatory guidelines.

Ensuring the integrity and safety of study drugs is paramount in clinical research. Our comprehensive study drug management solutions cover a range of essential services designed to streamline drug handling and administration while maintaining strict compliance with regulatory standards.

Key components of our study drug management services:

• Drug Re-labelling and Re-packaging: We facilitate drug re-labelling and re-packaging at clinical sites, ensuring accurate labeling and packaging that comply with study protocols.
• Drug Preparation under Aseptic Conditions: Our experienced team performs drug preparation under aseptic conditions for various parenteral administration routes, including intravenous, subcutaneous, intraarticular, intraocular, and intramuscular injections.
• Drug Dilution for Various Formulations: We specialize in drug dilution for oral, topical, or parenteral drug formulations, ensuring precise concentrations as required by the study.
• Local Drug Destruction Services: Safeguarding against expired or unfit-for-use medications is crucial. We offer local drug destruction services to responsibly dispose of medications that cannot be used.
• Drug Accountability and Inventory Management: Maintaining accurate drug accountability and inventory is fundamental to successful clinical trials. Our dedicated team ensures meticulous tracking and on-time monitoring of drug supplies throughout the study, providing you with peace of mind and confidence in your trial’s drug management processes.

At IRN Comac Medical we prioritize efficiency, accuracy, and compliance in every aspect of study drug management. Our goal is to support your research endeavors with dependable and quality-focused services tailored to your specific study requirements.

We offer comprehensive clinical site supply services to support the efficient and seamless operation of clinical trial sites. Our goal is to optimize supply chain management, ensuring that sites have timely access to the resources they need to conduct successful research studies.

What we provide:

• Timely and Reliable Procurement: We specialize in sourcing and procuring clinical trial supplies promptly and reliably. Whether it’s investigational drugs, medical devices, laboratory equipment, or consumables, we ensure that sites have access to quality supplies when they need them.
• Customized Supply Solutions: Every clinical trial is unique, and so are its supply requirements. We work closely with research sites to develop tailored supply strategies that align with study protocols and site-specific needs.
• Inventory Management: Our team oversees inventory management to prevent stockouts and excess inventory, optimizing supply levels to support ongoing research activities efficiently.
• Quality Assurance: We prioritize quality and compliance in all aspects of clinical site supply. We partner with trusted suppliers and adhere to stringent quality assurance protocols to uphold the integrity of study materials and equipment.
• Logistics Coordination: From shipping and distribution to customs clearance and warehousing, we handle logistics coordination to ensure seamless delivery of supplies to clinical trial sites worldwide.

Our focus is on enabling research sites to operate smoothly and efficiently, ultimately contributing to the success of your clinical trials.

At IRN Comac Medical, we believe that informed patients are empowered patients. Our goal is to enhance clinical trial experiences by providing comprehensive patient education and support throughout the research journey.

Here’s how we make it happen:

• Continuous Support: Patient education doesn’t stop at enrollment. We provide ongoing support and resources to patients throughout the duration of the clinical trial, addressing questions, concerns, and providing updates as needed.
• Empowering Patients: Our goal is to empower patients with knowledge about their condition, treatment options, and the importance of clinical research. We believe that informed patients are better equipped to actively participate in their healthcare decisions.
• Dedicated Patient Support: Our concierge team is committed to providing dedicated support to each patient, offering assistance with appointment scheduling, transportation coordination, and accommodation arrangements as needed.
• Personalized Care Plans: We tailor care plans to meet the unique needs of each patient, taking into consideration their preferences, medical requirements, and logistical challenges. Our goal is to make the clinical trial process as seamless and stress-free as possible.
• Local Expertise: With local knowledge and connections, our concierge team can recommend nearby amenities, restaurants, and attractions to enhance the overall experience for patients and their caregivers during their stay.

Together, we can make a difference in advancing medical research while prioritizing patient well-being and understanding.

At IRN Comac Medical, we understand the importance of providing comprehensive and convenient care to patients participating in clinical trials, and our experienced team is dedicated to meeting their unique needs. We offer specialized clinical trial nursing and physician services to support patients in the comfort of their own homes.

Here’s how our home care services can benefit your trial:

• Sample Collection: Our team can perform sample collection procedures efficiently and accurately, ensuring that specimens are collected according to protocol requirements.
• Intravenous Infusions / Injections: We offer skilled administration of intravenous infusions / injections, providing patients with the necessary treatments while minimizing disruptions to their daily lives.
• Centrifuge Operation: We can operate centrifuge equipment as needed for sample processing, maintaining the integrity of collected specimens.
• Observations/Vital Signs/ECGs: Our team conducts thorough observations, vital sign monitoring, and ECGs as required, providing valuable data for study assessments.
• Patient Education: We prioritize patient education, providing patients and their caregivers with the necessary information to understand their condition and treatment regimen.

Our team of clinical trial nurses and physicians are highly skilled and experienced in caring for research patients of all ages. Many of our patients have complex health conditions or rare diseases, and our team is adept at managing the unique challenges associated with these populations.

Whether your study involves pediatric patients, elderly participants, or individuals with multiple comorbidities, you can trust us to deliver compassionate and expert care.

Contact us today to learn more about how our Home Care Services can support your clinical trial and enhance patient recruitment, retention, and satisfaction.