Insights On Trial Design

  1. Is Your PM Advancing Your Study Or Checking Boxes?

    The Power of RTSM Problem Solvers on your Team - You spend an enormous amount of time assessing technology vendors through RFIs, pilots and capability presentations. Not only must the technology fit your needs, but you also make a judgement call based on the trust and value of the future relationship. Ultimately, the decision may weigh in favor of someone you can envision your team working well together.

  2. Is That IRT System Right For You? 5 Essential Questions To Ask

    We’ve been seeing a lot of messaging around agility in Randomization and Trial Supply Management (RTSM) or as some refer to it, Interactive Response Technology (IRT). Is “agile” becoming the new “innovative”? Does everyone understand what it truly means to be agile with regards to software development? What about project delivery? Both are equally important, but we can argue that agile software enables agile project delivery and not the other way around (which has its limitations).

  3. What Defines A Truly Global PRO?

    Global recruitment for clinical trials is far from a “one-size-fits-all” proposition. Enormous language, cultural, political, and socioeconomic differences exist in many of the countries that are becoming primary outsourcing locations for clinical research. Regional variations and cultural understanding of clinical research need to be taken into account when recruiting patients in these emerging markets.

  4. Defying Industry Assumptions With A Disruptive Approach To Solving Patient Enrollment Challenges

    Most Patient Recruitment Organizations (PROs) have essentially been doing the same thing for many years. Raising awareness of clinical trial opportunities and encouraging enrollment, their basic functions include: trial advertising and marketing communications, site support materials, study websites, and limited metrics tracking.

  5. The Challenge Of Recruiting Minority Patients

    Achieving patient diversity in clinical trials has long been challenging, and thus approved products may not be appropriately tested on representatives of the patient populations who end up using them. Even in conditions such as type 2 diabetes that impact ethnic minority populations in disproportionate numbers, racial and ethnic minorities are typically underrepresented in clinical research data. Some, however, are not seeing significantly lower minority interest in clinical trials relative to the percentage of minorities in the population. This suggests there is no underlying hesitancy or trepidation by minorities.

  6. Patient Centricity And Enrollment Certainty

    With the site-first approach to enrollment feasibility and completion continuing to struggle, sponsors are recognizing the need to embrace a patient-first strategy in order to complete enrollment on time or early. This requires truly understanding the patient as a potential trial participant relative to the study protocol, and owning the full patient experience, not just the trial journey.

  7. Phase I Studies: From First Drug Design To First-In-Human Studies

    Phase I is often seen as the gateway between scientific research and clinical medicine, and the outcome of the trials have a major impact on the next steps of any prospective drug.

  8. Solutions For Challenging Compounds Using Softgel Innovation

    The significant interest in semi-solid systems for the potential of extended release profiles has prompted researchers to develop alternative encapsulating systems. 

  9. Precision Medicine In Immuno-Oncology

    The ongoing advances in cancer immunotherapy together with precision medicine may promise a bright future for patients. Learn about the two most common biomarkers in clinical trials that are critical for the drug development process.

  10. Not Just Tiny Humans: Considerations For Conducting Pediatric Clinical Trials

    When it comes to the conduct of pediatric clinical trials, there are number of things you need to consider in order to ensure the successful conduct of a study. While we can’t predict the outcome, planning ahead for appropriate site conducting clinical studies in pediatric patient populationsand subject selection will take you one step closer. From study design to logistics to recruitment, there are real differences between studies conducted in pediatric populations and studies conducted in adult populations.