Right from the beginning to the very end of a study, let us source, train and manage the best CRA talent for you.
THE BENEFITS OF A GLOBAL CRO WITHOUT THE COSTS
We are an experienced and nimble Contract Research Organization with a deep network in the U.S., Eastern Europe, Western Europe and beyond
We find the patients you need, navigate each country’s unique regulations and reduce your costs and risks through our flexible vendor management structure.
global clinical trials
Who We Are
We are both a contract research organisation (CRO) and a vendor management organisation, with our mission being to help clinical trial sponsors run better trials.
We act as a concierge service, providing CRO services in some regions, while in others we will find and manage the best vendors, without adding on mark-up costs for the sponsor, thus creating the most cost-effective studies. Our focus is on transparency, reducing waste, and producing rigorous metrics.
Hiring local or niche CROs, labs, couriers and freelance Clinical Research Associates is logistically and financially complex, but our 25 years of experience in clinical research mean that we know precisely how to run trials, from protocol writing to site selection, from regulatory approvals to patient recruitment.
Successful studies are about usable information, which leads to effective treatments, which, in turn, leads to more lives saved – and that, ultimately, is why we’re in this business.
We have been successfully conducting clinical research for over 25 years, which has given us a unique balance of knowledge and expertise rarely available in the industry.
We’ve managed studies in almost every major indication, including cancer, autoimmune diseases, gastro-intestinal disorders, pulmonology, diabetes, neurology and psychiatry. We’ve worked with rare diseases, too, as well as vaccines and tropical medicinal products, though it’s cardiovascular mega-trials, including acute coronary syndromes and angina, that remain our main focus.
We’ve recruited and managed tens of thousands of patients in hundreds of hospitals in dozens of countries, and as a result saved countless lives. We’re proud of our work and keen to share our experience with future generations so that more lives can be saved.
Sergei Varshavsky, MD, PhD, and Confidence’s Chairman and CEO, played a major role in establishing the clinical trial sector in Eastern Europe.
Dr. Varshavsky began his medical career as an ambulance physician and then went on to become part of the mobile coronary care unit, before, in 1998, joining the Department for Urgent Cardiology at the Research Institute of Cardiology in St Petersburg. He started his PhD research into pre-hospital use of thrombolytic therapy in acute coronary syndromes and a year later was invited to serve as the national coordinator in the European Myocardial Infarction Project.
Dr. Varshavsky’s research group was one of the first Contract Research Organisations (CRO) in Eastern Europe, eventually adopting the name Evidence Clinical and Pharmaceutical Research. In 1999, Evidence moved its headquarters to the San Francisco Bay area, employing over 350 people, operating across seven offices in five countries and managing hundreds of clinical trials. In 2008, Evidence was acquired by Worldwide Clinical Trials.
In 2013, Dr. Varshavsky and Dr Kelman founded the aptly-named Confidence Pharmaceutical Research, to share their clinical trial experience and serve the biopharmaceutical industry.
Efim Kelman, Chief Operational and Medical Officer, has over 20 years of clinical and industry experience. Dr. Kelman had a noteworthy career in medical practice at the St Petersburg Institute of Research Institute of Cardiology before joining Evidence Clinical and Pharmaceutical Research, a CRO founded by Dr. Varshavsky. He served as COO, overseeing all of the clinical trials conducted by Evidence, including large-scale international cardiovascular studies as well as smaller studies in different indications.
Dr. Kelman reunited with Dr. Varshavsky to establish Confidence Pharmaceutical Research, where he is responsible for the supervision and management of most operational departments, as well as medical and operational oversight of studies.
Dr. Kelman holds an MD from Pavlov Medical University, St Petersburg, and an MBA from the Stockholm School of Economics.
Anna Ravdel, MBA, is VP of Business Operations and has 15 years of business experience. She served as director of Business Development at Evidence Clinical and Pharmaceutical Research, Worldwide Clinical Trials and Synergy Research Group, and collaborated with a range of pharmaceutical biotech companies both large and small, as well as other CROs. Ms. Ravdel rejoined her former colleagues Dr. Varshavsky and Dr. Kelman at the creation of Confidence, and together with them assists clients in setting up development goals and developing repeatable workflows and processes. She maintains documentation for Confidence’s client base and manages communication with local entities. She is also responsible for helping clients with contract terms, business development and marketing, and other business operations.
Anna Ravdel holds an MBA from the university of Manchester Business School, UK.
Breathing new life into clinical research.
Site monitoringRead More
Site SelectionRead More
By checking past performance, patient enrolment and work levels, we’ll ensure you’ll always choose the right sites for your studies.
Risk ManagementRead More
We’ll ensure you’ve planned for unforeseeable circumstances – and fix any mishaps as and when they arise.
Project ManagementRead More
Our coordination of your trial is meticulous at every stage, with metrics and controls applied with care to your specific needs.
Quality assurance and auditRead More
Conducting thorough audits, across a range of countries and languages, is an essential part of our service.
Investigator MeetingsRead More
We’ll keep your investigators engaged and responsive, with on-point meetings and a focus on performance.
Regulatory ApprovalsRead More
From scrutinizing optimistic promises to negotiating unfamiliar regulations, trust us to manage your regulatory approval timetable.
Investigator’s grantRead More
We treat principal investigators fairly, helping to drive credible study results and build stronger relationships between the industry and physicians.
Translation and ValidationRead More
Our translation process isn’t just about words, it’s about communicating effectively and sensitively across cultural boundaries.
BUSINESS CONSULTANCYRead More
Whether you’re selling, growing or downsizing, your toughest challenge is managing successful change. Let us guide you.
Medical Writing and SafetyRead More
Leverage our experience to create better trial protocols and study reports to improve trial outcomes and safety records.
Data management and statisticsRead More
We’ll help you choose the perfect up-to-date technology to make sure you have the tools to make the most of your trial data.
May, 17WHAT A SPONSOR NEEDS TO KNOW ABOUT CROS
What is driving the use of contract research organizations (CROs) by biotechnology, pharmaceutical and institutional sponsors? The driving factors include:
May, 02How to Navigate Country-Specific Regulations in Global Clinical Trials
Are you aware of the worldwide differences in regulations for global clinical trials? Among other factors affecting global clinical trials,
Apr, 25How to Ensure Good Clinical Practice in Global Clinical Trials
Any contract research organization (CRO) conducting a global clinical trial knows that the definition of good clinical practice (GCP) has
Tokyo-based Astellas Pharma and New Jersey-based Chromocell have announced that they have entered into a licence and collaboration agreement for the
California-based Aerie Pharmaceuticals has announced the results of its second Phase 3 trial for Rhopressa, a once-daily, triple-action eye drop
Dublin-based ICON has announced that it is working with IBM to help reduce the time and costs of drug development,
GET IN TOUCHBurlingame
1633 Old Bayshore Highway, Suite 328
Burlingame, CA 94010, USA
Anna Ravdel: +1 (401) 965-3377 [EST];
Efim Kelman: +1 (650) 575-2213 [PST].