Clinical Study Setup & Management
ADB Consulting provides a full suite of Clinical study Setup and Management services. ADB Consulting Assembles a team based on your project requirements. The team would consist of seasoned, experience and professional staff form Project Directors to Clerical Staff.
Our Staff will assist in developing a Study Management Plan that will dictate the services and resources required for individual studies. Our Main goal is to ensure that studies are executed efficiently and effectively with the highest quality and integrity.
Below we attempt to describe some of our services. Study Setup and Management are separated in the description below; however, they maybe applicable in both categories.
Study Setup Services
Some of our Clinical Study Setup services are:
Clinical Protocol Development
CRF Development
On-Site Study Setup Activities
Investigator Meetings
Site Enrollment
Site Initiation and Training
++++ MORE
Study Management Services
Some of our Clinical Study Management services are:
Patient File Setup
Patient Enrollment
Patient Selection (Inclusion/Exclusion)
Randomization
Product Order and Disposition
Data Management
Electronic Data Capture
Remote Data Capture
Adverse Event Handling
Medical Coding and Categorization
Adverse Event Auto Encoding (MEDDRA)
Medication Auto Encoding (WHODRUG)
Data Safety Monitoring Board Review
Electronic Logic Check Programming
Query Generation and Resolution
Study Monitoring
CRF Monitoring
CRF Auditing
Sponsor and Site Audits
Regulatory Inspection Preparedness
Study Audits
Study Close-Outs
SEE INDIVIDUAL BROCHURES FOR DETAILS
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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