Clinical Trials Setup, Conduct, and Management

Medical device clinical trials are the main focus of our business.

Your company specializes in manufacturing medical devices and probably do not have internal capabilities and resources to run Clinical Trials on the device to evaluate patient benefits including safety, efficacy, and risks. This is where GCM comes to rescue. We support you through all phases of clinical trial development, management, and testing of the device.

Some benefits of conducting Clinical Trials:

• Know Patient benefits and risks (Safety and Efficacy of device)
• Identify areas of improvement to device
• Publications of statistical results and other relevant findings in scientific magazines
• Comparison of your device to competitor
• Get ahead of competition who have not conducted any clinical trials
• Obtain Regulatory pre-market approval
• Get FDA approval for marketing the device
• Claims and capture more market for your product
• Monitor post-market product use for several years to establish safety and efficacy profile

GCM has expertise in:

• Create and develop Clinical Trial strategy, Protocol design (Identify Safety and Efficacy endpoints), and Case Report Forms
• Determine the appropriate number of investigator sites and patients, duration of trial and length/schedule of patient follow-up
• Prepare necessary documentation for IRB and/or Ethics Committee and get approval to conduct trial
• Enroll best study sites and investigators for your medical device
• Investigator Site Training on Protocol, study device, related materials and good clinical practices
• Trial Monitoring  for full duration of Trial to ensure that your trial is performed in accordance with FDA regulations and GCP/ICH guidelines
• Secure storage and archiving of source trial data for any potential audits
• Data Capture and Statistical Analysis
• Maintain adverse events database

Investigators we enroll in clinical trials have capabilities to enroll prospective patients and the sites maintain all necessary equipments for patient assessments.

At any time we are able to provide you status reports on number of patients enrolled, number of visits completed, number of patients withdrawn etc.

Below are some of the medical devices for which we can help conduct clinical trials:

• Knee Implants
• Hip Implants
• Spinal fusion implants
• Fracture fixation devices
• Reconstructive joint devices
• Spinal fixation devices
• Bone matrix devices
• Joint injection therapies
• Bone growth factors
• Stem cells for spinal fusion
• Tissue engineered orthopedic implants

Data Management Database Design Statistical Analysis