Clinical Study Monitoring & Auditing
ADB Consulting offers clinical study monitoring and auditing services across all phases of clinical trials. Some areas of therapeutic experience includes: Alzheimer’s, Cardiovascular, Depression, Dermatology, Diabetes, Infectious Disease, Medical Devices, Oncology, Pain Management Stroke and more.
The companies below are a few of those that our associates have supported in the past:
Abbot, BMS, Boston Scientific, Johnson and Johnson, Gore, Medtronic, Pharma, + many others.
ADB Consulting supports both startup and long standing companies. Our project teams grows to support any size /phase projects.
Clinical Study Monitoring
ADB Consulting manages a network of in-house and contract clinical research associates (CRAs) who have experience in a broad range of therapeutic areas.
Our CRAs understand your study and the importance of a professional relationship with investigators, site coordinators and site personnel. ADB Consulting CRAs are dedicated to obtaining the highest quality data for your study. The services provided include but is not limited to: Pre-Study Qualification Visits, Data Monitoring Plans, Initiation/Interim/close-out Monitoring Visits, and Clinical Study Monitoring Reports.
Our main clinical study monitoring goal is to ensure that the reported data are accurate, complete, verifiable to source documents. In addition to our goal, we aim to confirm that the trial is conducted in compliance with the protocol, GCP/GLP, and FDA regulatory requirements.
Clinical Study Auditing
Study auditing is one of the most important activities of a clinical trial; it reassures the readiness of the trial for inspection by the regulating agencies.
We deduce the accuracy of data collected and entered in databases to its source at the clinical sites.
We ensure that all regulatory aspect on a site by site, investigator by investigator, and patient by patient basis follows FDA guidelines.
Allow ADB Consulting to confirm your confidence with your trial prior to subjecting to submissions and inspections.
Related Services:
Clinical Study Setup Clinical Study Management Clinical Study Monitoring Clinical Study Auditing Data Management Bio-Statistics Medical Coding Drug Coding Adverse Event Coding Data Analysis Reporting Staffing System Validation
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