Clinical Trial Services
Developing novel pharmaceuticals, biologics and medical devices is your focus. Your internal resources and available intellectual capital strive to deliver cutting-edge innovations that will keep your organization at the forefront of your field.
HCRI will help validate the scientific integrity of your work. As an academic research organization (ARO), HCRI adheres to a strict conflict of interest policy that helps to preserve public trust in scientific results.
HCRI Connects Academia to Industry
HCRI-affiliated academic physicians provide insight into the impact and practicality of emerging products. Their participation in design, oversight and analysis can ultimately lead to approval by regulatory authorities and product adoption by the medical community.
HCRI works with a broad range of sponsors including small start-ups, multi-nationals, the NIH and investigators. The Institute meets industry standards and aggressive timelines and offers price-competitive services that span the entire clinical trial process.
The department is well-known for its expertise in designing and analyzing clinical trial data and for providing comprehensive statistical services for single- and multi-center trials.
The team assesses and designs clinical research programs according to a sponsor's needs and industry landscape for all phases of development from first-in-man through Phase IV post-approval trials.
The CEC Services group is comprised of experienced nurses and physicians with medical backgrounds specific to your trial, who provide comprehensive medical review and adjudication of clinical endpoints.
A multi-disciplinary clinical background enables the group to provide effective process monitoring including collection and triage of all safety information throughout the trial.
The data management staff has extensive experience in all areas of data management, including data collection tool design, database design and development, query management, coding, SAE reconciliation, and EDC data management.
HCRI provides DSMB services led by industry thought-leaders and unique to the needs of each trial.
All tracings in the lab are read by board-certified cardiologists and electrophysiologists with expertise in waveform and arrhythmia analysis. The lab also specializes in analyzing Holter/loop recordings in atrial fibrillation therapeutic trials.
The EQOL Group is dedicated to providing economic assessments that aid in the development of new medical therapies.
HCRI provides comprehensive EDC services to accelerate the study process from the clinical database design and build, through acceptance testing, user training, and launch.
Each trial is assigned a dedicated lead who serves as the primary point of contact and creates and manages the project team from all functional areas.
The site management group is the vital link between the sponsor and the site. It provides full site support and monitoring from study start-up to close-out.
