The European medical regulatory landscape is undergoing its most significant overhaul in years. The eagerly-awaited Medical Device Regulation (MDR), published in May 2017, will bring substantial changes to the way medical device manufacturers bring their devices into the European market. Download this white paper and discover nine important factors for the successful planning, development and maintenance of a Clinical Evaluation Report (CER).
Bringing a new medical treatment to market is a challenging process - one that is not always fruitful. It is estimated that clinical development programs fail four times out of five. Although a clinical trial can fail for many reasons, poor trial design is often the main cause for failure. Download this white paper and discover the most important steps in successfully designing your clinical trial.
Insourcing or outsourcing in clinical trials is a late-breaking topic. Despite other branches of trade such as the automotive industry where large companies are experiencing a comeback of insourcing, the conduct of clinical trials are mostly outsourced to contract research organizations (CROs). Download this white paper and discover the benefits and challenges of both insourcing and outsourcing and what to take into consideration when outsourcing.
The pharmaceutical and medical device industries continuously look for opportunities to effectively and efficiently manage data collected in clinical trials to deliver meaningful treatments to those in need. Download this white paper and discover the biggest trends in data integration that could reduce overall trial cost and accelerate the flow of critical information to key stakeholders.
The healthcare industry is witnessing many changes in this digital era. A recent revolutionary development in digital health technology is software that can perform complex medical functions - software as a medical device (SaMD). Download this white paper and discover why implementing a regulatory strategy early in the development will go far in bringing you closer to successful market access of your SaMD.
Despite industry efforts, success rates in oncology clinical trials have been declining over time. More and more device-based therapies and interventions are being developed however, delivering promising results in cancer diagnostics and treatment. Download this white paper and discover that therapeutic leadership and specialized operational teams have become essential to obtain maximum efficiencies while conducting oncology clinical trials.
If sponsors want to enroll and retain patients, they must take steps to mediate the information overload & falsehoods that their patients are exposed to and continue to establish trusting relationships with them. Download this white paper and discover the most important factors in successfully driving recruitment, enrollment and completion of your clinical trials.
Ensuring proper data protection in a clinical trial is a demanding & expensive process, one that may leave an organization vulnerable to data breaches, resulting in steep fines and penalties. Download this white paper and discover the most important actions that can be taken to understand and prepare for the new GDPR.
Whether you are a first-time inventor or a large manufacturer with a rich history in bringing medical devices to the market, the thrill of being at the forefront of an innovative concept is both exhilarating and overwhelming. The development of a successful medical product not only requires optimized engineering design efforts, but also clinical, regulatory, marketing and business expertise. Download this white paper and discover the most important steps in successfully launching a medical device.
When being introduced to the world of market access and health economics, the staggering number of abbreviations can be overwhelming: HTA, QALY, DRG... What should we make of all these terms and how should we interpret them? Download this white paper and discover reimbursement and market access in key markets, success factors, the decision makers, and differences in payment systems.