Your Project.
Our Priority.

What experience do you have with trials in this therapeutic area?
Understanding the CRO's experience in your specific area of interest can help gauge their expertise and potential challenges they've overcome.

HCC has conducted 100+ clinical trials in the Cardiovascular, Neurological, Peripheral vascular and other therapeutic areas.
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‍How do you approach trial design to ensure it meets regulatory requirements and scientific objectives?
‍This question addresses how the CRO ensures that the trial's design is robust, can achieve its objectives, and complies with regulatory standards.

HCC understands the key aspects of clinical study design that will provide a final result that meets all the Sponsors objectives and facilitates a successful regulatory approval. Our experience includes large, randomized IDE/PMA studies, 510(k) studies and post-market studies. In addition, HCC has conducted trials in numerous OUS geographies (Europe, Australia, New Zealand) where HCC navigated the various regulatory requirements by country ensuring a successful outcome for our Sponsors.
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‍Can you assist with protocol development and if so, what is your process?
‍Developing a strong protocol is critical. Knowing how the CRO can assist and improve this process is valuable.

With over 30 years of clinical trial experience across a wide range of therapeutic areas, HCC knows the critical inputs of a clinical study protocol that will ensure trial success. From selecting the right inclusion/exclusion criteria to identifying the most important data to collect for a Sponsors particular endpoint.

What is your project management structure? How frequent and through what means will we communicate?
‍Effective communication and a clear project management structure are key to the smooth running of the trial.

Project management is the foundation for a successful clinical study and HCC has a team of experienced Project Managers that are here to manage our Sponsors studies. Our Project Managers are the direct point of contact for our Sponsors so that there are no barriers to communication between our Sponsor and the Project Team. HCC’s Project Managers understand the needs of today but are focused on what is coming tomorrow, next month and next year.

‍How do you handle unexpected challenges or changes in the trial?
‍This question addresses the CRO's flexibility and problem-solving capabilities.

Our experience has shown, all clinical trials will have changes from when they are first designed to the final database lock. Whether it is a change in a primary endpoint, the addition of new clinical sites or delays in enrollment, HCC has seen it all and our Project Managers establish numerous contingency plans throughout the study so that if a roadblock is met, our Team has already established a pathway forward keeping the study on track.

Can you provide a detailed budget breakdown? What costs might be incurred outside of the quoted budget?
‍Understanding all potential costs upfront can help in budget planning and avoid unexpected expenses.

HCC provides a very thorough proposal at the beginning of the process that includes all the potential costs we feel are needed to have a successful clinical trial. Our experience has shown that our initial proposal rarely requires change orders to address items that were not identified by HCC at the beginning.

‍What is your policy on contract amendments if the scope of the trial changes?
‍Flexibility in the contract to accommodate changes is crucial for adapting to unforeseen circumstances.

If there is a change in services required or a new service is requested, HCC collaborates with the Sponsor to develop the most cost-effective solution for the Sponsor.

How do you ensure compliance with local and international regulations throughout the trial?
‍Compliance is crucial for the validity of the trial and for the safety of participants. Experience in diversified trials across geographical regions insures a CRO is capable of navigating the complicated regulatory landscape.

HCC has a robust Quality System that is the foundation for all our processes and procedures that comply with both US (FDA) and OUS regulations. Our Quality department participates in all our projects ensuring that the team at HCC is in compliance with the most up to date regulatory requirements.
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‍Can you provide support with regulatory submissions and interactions?
‍Understanding the extent of their regulatory support can streamline the approval process.

Through experience with various levels of trial in support of IND, 510(k), IDE/PMA, CE Mark, HCC's team can help a Sponsor with any regulatory submission and interactions either in the US or outside the US.

How do you ensure the ethical conduct of the trial and the safety of participants?
‍The CRO should have clear procedures in place for ethical oversight and monitoring participant safety.

All HCC trial personnel are trained in Good Clinical Practices (GCPs) which is the foundation for running a clinical study. HCC has a dedicated Safety Team that participates in our studies where they routinely review adverse events and reviewing with CEC/DSMB panels as required to ensure the safety of all trial participants.

‍What is your process for handling adverse events or unanticipated problems?
‍Knowing how the CRO will deal with safety issues is essential for participant protection and regulatory compliance.

HCC’s dedicated Safety Team relies on a database of safety events we have collected and the extensive experience of our Team to review events in all of our studies in real-time so that if there are any events that are not anticipated, the proper reporting to the regulatory agencies or clinical sites can happen in a timely manner.

How do you manage clinical trial data effectively?
‍Effective data management requires a thorough understanding of the types of data collected, identifying how data will be captured, processed, and stored.

HCC knows compliance is crucial for the validity of the trial and for the safety of participants. Experience in diversified trials across geographical regions insures a CRO is capable of navigating the complicated regulatory landscape.
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What are some best practices for data management in research?
‍Best practices include setting up a comprehensive data management process, clear communication of requirements, identifying necessary data, and ensuring data security and compliance.