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The high failure rate of clinical trials has significant impact on providing potential curative treatments to patients in need. It is with this goal in mind that innovators struggle in designing clinical programs that can bring life-changing treatments to market. Drug development remains a high cost and risky undertaking, given the high failure rate if […]

In the US, pharmaceutical and biotechnology companies sponsor the majority (75%) of clinical trials. In total, these companies spent approximately $40 billion on clinical research in 2014. [1] Clinical trials such as these are the first point of interaction between a patient and a sponsor company. In spite of this, clinical teams frequently overlook this […]

This is the third and last part of a 3-part series on strategic considerations for patient engagement, market access and promotion for medical devices and procedures. In this blog, we’ll discuss the important factors from the Company’s perspective. We’ll look to discuss what the mission critical factors are for device success, after you’ve completed all […]

This is the second part of a 3-part series on strategic considerations for patient engagement, market access and promotion for medical devices and procedures. In this blog, we’ll discuss the important factors from the payer’s perspective that many times are overlooked and not given their full due by well-meaning corporate teams. As an early disclaimer, […]

This is the first part of a 3-part series on strategic considerations for patient engagement, market access and promotion for medical devices and procedures. We will discuss what many times gets overlooked, de-prioritized, or lost in the gaps by well-meaning corporate teams. The end first – “If you do not change direction, you may end […]

The confetti has cleared the air, the champagne bottle is empty and the sun is shining on the day after your device has gained FDA clearance. You want to believe the hard-part is over and from here on it is smooth sailing into the sunset, with an umbrella drink in hand, and payers in line […]

We’ve all been there before if you’ve been doing clinical trials for some time: the protocol is approved, patients are recruited and enrolled, clinical sites engage and monitor their patients and then the happy day of the last patient visit. However, don’t pop the bubbly just yet because the database needs to be locked and […]

Clinical trials are more complex, more involved and span the globe. Clinical trials involve people, patients, stakeholders, researchers, administrators, and regulators, to name just a few. Next: add on training, monitoring and oversight to provide quality data in a short time-frame and you have a recipe for disaster! What’s a poor boy (or girl) to […]

In clinical trials, sponsor companies are trying to prove that their therapy is effective and safe for patients to use. A critical component of the clinical trial is the patient. Recruitment and enrollment is a top priority for all clinical trials because without volunteers, there is no data to show that a therapy is safe […]

The goal in any clinical trial is to test a drug or therapy to find out what the benefits and risks are to the patient, and if that therapy should ultimately be made available to the general public. In order for this to happen, the Sponsor Company, clinical investigators and clinicians need accurate, unbiased and […]