Clinical Trial Monitoring

Education in clinical trial monitoring is seen as the differentiator in staving off FDA from derailing trials.

“Better to get bad news from us than from the FDA,” says trial monitor Mary Maddock, during a MedCity News interview. Ultimately, every successful clinical trial must safely negotiate the rocky shoals of trial monitoring in order to win coveted FDA approval. A good trial monitor can speed trials and smooth the regulatory approval process.

“Education helps keep researchers from making mistakes,” adds Neal Fearnot, chairman of MED Institute Inc. in West Lafayette, IN. “Significant education for the staff, physicians, hospital administrators–anybody who’s on site and involved with running the clinical trial.” Education helps to avoid an FDA Form 483 warning, which is followed by significant added paperwork for the violation… and/or a complete halt to the clinical trial.

Best-in-Class Clinical Trial Monitoring Features:

• Oversight, administrative due diligence, and ongoing education by monitors throughout the trial’s duration
• Data collection and analysis throughout a project to ensure appropriateness of the research and project design.
• Comply with informed consent and human subject protection requirements

Top Considerations before Engaging Clinical Trial Monitoring Providers:

From project management and clinical trial monitoring or simply to supplying a small team of monitors to work on a study, providers should be experienced in clinical site monitoring, experienced across all phases of development and major therapeutic areas, possess the ability to recruit, educate and train both test subjects and staff for either regional or in-house monitoring.
 
Key Products:

1. With a network of in-house and contract clinical research associates with expertise in a wide range of therapeutic areas, Statking Consulting provides laboratory pre-study qualification visits, clinical study monitoring, initiation plan monitoring, close-out monitoring visits, and clinical study monitoring report. With a network of in-house and contract clinical research associates with expertise in a wide range of therapeutic areas, Statking Consulting provides laboratory pre-study qualification visits, clinical study monitoring, initiation plan monitoring, close-out monitoring visits, and clinical study monitoring report. A data-related service Contract Research Organization (CRO), Statking Consulting, Inc. was founded in 1989 and has provided support on over 250 clinical trials. In addition to providing biostatisticians, data managers, clinical study monitors, project managers and medical writers for clinical research teams, Statking Consulting offers protocol development, IRB submissions, site and laboratory qualification, regulatory documentation, investigator meetings, drug/device accountability.

2. Stiris Research Inc. offers site identification and feasibility studies, site qualification visits, site activation, informed consent review,  review of policies, procedures and documentation, data collection (electronic or paper), query resolution, and ongoing monitoring of site/study recruitment. Founded in 2004 as an independently owned, clinical research consulting company, Stiris Research provides functional service or full service clinical trial support for pharmaceutical, biotech, and device companies. In 2009, in order to automate the clinical trial process, Stiris Research implemented clinical trial management software (CTMS) from Clinical Force.

3. Providing integrated solutions from preclinical activities to Phase I-IV trials, bioanalytical, trial monitoring, and QC testing, SGS's Life Science Services is a global contract service organization, with further capabilities for rapid access to special patient populations for time-critical trials.  SGS serves the pharmaceutical, biotechnology and medical device industries. An experienced global CRO for 30 years with over 2,000 clinical trials performed, SGS has two Phase I centers in Europe (Paris/Antwerp) with 184 total beds; Phase I-IV clinical trial coordination centers in ten offices covering Europe and the US; and  two bioanalytical laboratories in France and Belgium. Clinical trial management specialties in infectious diseases, CNS and cardiology; biometrics pioneer in use of EDC systems for Phase I to IV studies and monitoring.

4. Essential Group (now part of InVentivClinical) offers in-house and regional trial monitors with an average of more than 13 years of experience in clinical site monitoring. Essential Group offers protocol development and study design, feasibility study, project management, rapid study startup, clinical monitoring, medical monitoring, data management, patient recruitment and retention, statistical analysis, medical writing, PI training services as well as patient recruitment and retention services. Essential Group was founded in 1994 and formerly known as AmericasDoctor, Inc. (until name change in January of 2005). The company’s client base consists of pharmaceutical, biotech, nutritional and medical device companies. As of February 20, 2010, Essential Group was acquired by inVentiv Clinical Solutions, LLC.

5. ClinAudits specializes in conducting GCP audits, GLP audits, GMP audits, and GTP audits, but does not conduct or manage clinical trials. The company performs multiple types of audits in GCP, both domestically and internationally including, but not limited to, investigator sites, CRO (pre-qualification or post capability), IRB, final study reports, central labs, phase 1 units, computer validation, and mock FDA/EMEA pharma-covigilance and database audits. ClinAudits provides Good Clinical Practice (GCP) regulatory compliance and auditing services to the pharmaceutical, medical device, biotechnology, biologics industries, and to major academic institutions.

Clinical Trial Monitoring
Definition: Clinical Trial Monitoring of a clinical trial requires oversight and administrative efforts that monitor the trial throughout its duration, including data collection and analysis throughout a project to ensure appropriateness of the research and project design, validity and integrity of the data, and protection of human any subjects.