Focused compliant execution of clinical programs on a worldwide scale

Our Clinical Operations services—providing comprehensive support throughout clinical trial phases extending from Phase II to Phase IV—reflect our commitment to always orchestrating a seamless project symphony from the first note to the last. A highly specialized, integrated project team is at the core of these efforts, with every member dedicated to your project’s success while offering the benefit of a single, responsive point of contact to facilitate efficient communication/coordination during all stages.

Our slate of service offerings, meanwhile, was assembled based on inclusive, globally compliant processes to ensure all regulatory requirements are met/maintained throughout the trial life cycle. Projects are always meticulously monitored, with performance measured against contractual timelines, quality metrics, and a strict adherence to agreed-upon budgets.

Zooming in, our strongest expertise lies in our ability to optimize clinical trial design: crafting protocols tailored to maximize both efficiency and the quality of data collected. Our steadfast dedication to patientcentric methodologies further supports these efforts, ensuring the patient experience is not merely one consideration but instead the central focus of our trial design strategy. The corresponding benefit? A twofold impact that boosts subject recruitment and retention rates while optimizing site productivity, paving the way for more successful (and efficient!) clinical trials.

Service

Core Clinical Operations service offerings include:

  • Site Selection and Feasibility

    At CliniRx, we recognize these two phases are nothing short of critical for the meticulous planning and execution of global clinical trials: understanding that a well-crafted feasibility and recruitment strategy, complemented by dedicated patient recruitment/retention teams, can significantly expedite enrollment and minimize patient dropouts. It’s to this end that we lean on the strength of our extensive global site network and well-established relationships with investigators and key opinion leaders

    Our comprehensive approach, meanwhile, calls for dedicated trial site identification and evaluation efforts spanning diverse geographic regions. In doing so, we always consider the nuances of the local regulatory landscape/patient demographics and healthcare infrastructure quality before conducting rigorous feasibility assessments to gauge the suitability of these sites: zeroing in on their ability to meet trial-specific requirements and thus evaluating their patient recruitment/retention capabilities. All in all, these collective efforts are designed to ensure not only the success but also the overall efficiency of the global clinical trials we’re proud to help launch.

  • Site Management

    We designed our Clinical Trial Site Management services to ensure speedy, proactive support that both clients and sites can depend on during clinical trial planning and execution stages all the way through to the closeout. Knowing full well that the success of our clients' endeavors hinges on a seamless progression from one clinical trial stage to the next, we go out of our way to forge strong, collaborative relationships with each and every site we partner with.

    With all of the above in mind, our experienced clinical research associates (CRAs) dedicate themselves to ensuring all studies are executed with unparalleled quality at every site: collaborating with site teams to deliver high-quality data with help from our established procedures/tools and always adhering to global/regional regulations. They also provide site staff with ongoing training and support—with respect to trial protocols, regulatory requirements, data-collection procedures, and optimal recruitment strategies—to boost overall engagement/motivation. Our CRAs continuously engage with sites to quickly address any queries, concerns, or challenges that pop up.

    Their work spans the following

    • Site assessment and activation
    • Clinical monitoring through every clinical trial stage
    • Site budgets and contract management
    • Payment administration
    • Site documentation preparation
    • Patient recruitment and retention
    • Ethics committee and regulatory documentation submissions
    • Drug accountability
    • Site closeout
    • Site audit support
  • Clinical Monitoring

    Clinical Trial Monitoring services tailor-made to meet your specific clinical study needs

    Our Clinical Monitoring services are meticulously crafted to enhance overall clinical study quality. We kick-start the process by formulating a comprehensive monitoring plan that outlines all details and specifiesthe source data verification (SDV) level: leveraging a data-driven approach that allows us to tailor our monitoring strategies to the unique demands of each study and then adjust accordingly based on site performance and activity. At the heart of this service is our highly skilled clinical research associate (CRA) team comprised of experts who bring a wealth of clinical research expertise and therapeutic experience to the table. Their primary focus is on critical elements (e.g., subject eligibility, study enrollment, protocol adherence, and data) so vital for subject safety and endpoints, with emphasis placed on maintaining strict adherence to ICH-GCP standards to safeguard trial integrity. Our well-structured approach, combined with periodic co-monitoring and project-specific plans, ensures all trials benefit from consistent, quality oversight. Moreover, our CRAs actively engage in face-to-face meetings with investigators on a regular basis to exchange findings and recommendations, address potential retraining needs, and cultivate a collaborative atmosphere that strengthens site-sponsor relationships. Not only does this approach guarantee site protocol adherence, but it also enables the timely resolution of pending action items and thus paves the way for dependable, robust clinical trial findings: a true win-win!

    With clinical monitoring representing a significant chunk of the total study budget, CliniRx staffs both local and regional monitoring teams with experienced CRAs who possess in-depth knowledge of local regulations, standard of care, language, and cultural nuances. These CRAs are strategically positioned across our offices in the USA, UK, The Netherlands, Spain, Hong Kong, India, as well as in approximately 12 other countries, ensuring close proximity to prominent research sites. CRAs thus provide invaluable local support to sites, communicating in the local language and within the context of specific protocols.

  • Vendor Management

    In the labyrinthine clinical trial landscape, CliniRx’s Clinical Trial Vendor Management services help diverse vendors and service providers engage in productive collaboration with the benefit of efficient, quality solutions designed to optimize the sponsor-vendor relationship throughout the trial life cycle. Whether we’re tackling initial vendor selection or ongoing oversight and performance evaluation activities, our experienced team ensures all vendors align with study objectives and are in full compliance with regulatory standards.

    We also leverage our extensive network to facilitate transparent communication, streamline processes, and mitigate risks: ensuring vendors deliver their services with the utmost precision. A dual focus on cost-effectiveness and quality assurance, meanwhile, arms our Vendor Management team with the ability to make significant contributions driving overall clinical trial success while allowing sponsors to navigate research complexities with (exhale) confidence and ease.

    Our dedicated teams manage a diverse range of vendors including (but not limited to) central laboratories, clinical suppliers, logistics management companies, translation providers, IVRS experts, and eClinical solutions companies (CTMS/eTMF, RTSM, EDC/ePRO, and eConsent). Whether we’re onboarding a new vendor or managing existing vendors mid-study, CliniRx has all related details covered…

    • Quickly identifying/evaluating vendors, guaranteeing a swift and efficient selection
    • Negotiating terms per study objectives to forge best-value agreements
    • Optimizing savings by maximizing cost-effective clinical trials practices
    • Monitoring the entire project life cycle to ensure vendors comply with regulatory standards while maintaining transparency given robust vendor-management policies

Experience supporting small Biopharma bring New Drug to Market!

We’ll be happy to discuss further.