The relationship between a clinical research monitor and site coordinator can play a major role in ensuring data integrity and compliance with applicable regulations. Positive relationships can foster timely data entry, rapid resolution of queries, and adherence to FDA regulations. On the other hand, strained relationships can delay data entry, prevent resolution of queries and […]
IMARC
The Future of the FDA: A Clinical Research Associate’s Perception
There are many stakeholders involved in conducting a clinical trial today; however there can be many challenges to the infrastructure of running a clinical trial. Challenges that are seen with running medical device trials can vary anywhere from securing funding to lacking time and having dedicated study personnel. Another challenge that is faced is the […]
An Infographic: Comparing Drugs & Devices Trials
Several years ago, IMARC Research published a whitepaper outlining the differences between Drug and Medical Device clinical trials. Since IMARC focuses primarily on medical device trials, we felt it was important to highlight the differences between the two trials. It has proven to be one of our more popular whitepapers, so we have decided to […]
In Vitro Diagnostics – The Basics
It has been estimated that In Vitro Diagnostics (IVD) will play a role in around 70% of health care decisions, and market estimates predict the IVD market will be close to 75 billion dollars in 2010. The role of IVDs in health care decisions should only continue to grow as healthcare shifts away from a […]
IMARC launches new clinical research services
IMARC, a clinical research organization, is introducing new services designed to better assist research professionals as they secure regulatory approval. IMARC has been a trusted source of independent monitoring, auditing, training and consulting for nearly two decades. The expanded offerings are a response to the growing needs of clinical research sites who often face high […]
Changes to the FDA routine inspection plan: Will this help the FDA?
In the clinical research industry, approvals for investigational products are not granted- they are earned. Increasing numbers of FDA early-intervention and routine inspections can increase the stress levels of everyone involved in clinical trials. Auditing can be looked at as a quality assurance process, and a way to prepare for inspections and approval by: Identifying […]
The history of clinical research eBook
For clinical research professionals, the protection of human subjects has always been of paramount importance. Doing so while ensuring accurate and credible data are obtained are the primary roles for every individual on a research team. Unfortunately, history reminds us that unethical research practices and/or disregard for the well-being of human subjects has not only […]