- Launched his first international clinical trial in a cardiology clinic basement in 1989.
- Founded Evidence Clinical & Pharmaceutical Research; built it into a leading contract research organization in Eastern Europe before it was acquired by Worldwide Clinical Trials.
- Clients have included Pfizer, GlaxoSmithKline (GSK), Bristol-Myers Squibb, Boehringer Ingelheim.
- Has conducted hundreds of major clinical trials and authored more than 40 published scientific papers.
- All 6 Best Practices
- Pre-Call Discovery Process
- One-on-One Call with Expert
- Session Summary Report
- Post-Session Engagement
- Clinical Trial Management System (CTMS)
A customizable software system used by biotechnology and pharmaceutical industries, specifically in clinical research institutions, to electronically manage large amounts of data involved with the operation of a clinical trial. The system maintains and manages all planning, preparation, performance, and reporting completed during clinical trials. It also maintains up-to-date participant contact information, tracking deadlines and milestones.
- Data management plan (DMP)
A plan that documents the processes for handling the flow of data from collection through analysis. Software and hardware systems along with quality control and validation of these systems, as relevant are described
A product's ability to produce beneficial effects on the duration or course of a disease. Efficacy is measured by evaluating the clinical and statistical results of clinical tests.
Overall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death.
- Inclusion/exclusion criteria
- The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.
A medical professional, usually a physician, but may also be a nurse, pharmacist or other health care professional, under whose direction an investigational drug is administered or dispensed. A principal investigator is responsible for the overall conduct of the clinical trial at his or her site.
- The formal evaluation of the quantitative evidence from two or more trials bearing on the same question. This most commonly involves the statistical combination of summary statistics from the various trials, but the term is sometimes also used to refer to the combination of the raw data.
- Person employed by the sponsor or CRO who reviews study records to determine that a study is being conducted in accordance with the protocol. A monitor's duties may include, but are not limited to, helping to plan and initiate a study, and assessing the conduct of studies. Monitors work with the clinical research coordinator to check all data and documentation from the study.
- Orphan drug
A designation of the FDA to indicate a therapy developed to treat a rare disease (one which afflicts a U.S. population of less than 200,000 people). Because there are few financial incentives for drug companies to develop therapies for diseases that afflict so few people, the U.S. government offers additional incentives to drug companies (i.e. tax advantages and extended marketing exclusivity) that develop these drugs.
- Principal investigator (PI)
The person who is responsible for the scientific and technical direction of the entire clinical study (for example, for all sites of a multisite study).
The written description of a clinical study. It includes the study's objectives, design, and methods. It may also include relevant scientific background and statistical information.
Individual, company, institution or organization taking responsibility for initiation, management and financing of a clinical trial.