Insights On Trial Design

  1. Caregivers - The Missing Link to Patient Centricity

    Caregivers are an integral part of the care team and are involved in everything from medication choice to adherence strategy. Yet, they’ve often been an afterthought for life sciences companies, even as the industry focuses on patient centricity.

  2. Health Consumer Mindsets

    How are consumers engaging with their healthcare in today’s environment and what drives engagement, and what hinders motivation or ability to engage? This study explores these questions.

  3. Study Change Requests – A Test Of Agility, Efficiency And Experience

    With study protocols are becoming more complex with changes that require amendments it is crucial to find a partner that can define, build, test, confirm, and deploy quality studies.

  4. Building Faster, Patient-Centric Studies In A Changing Regulatory Environment

    IRT USA 2018 resonating themes - the need for better project management and never losing sight that the patient is at the center of everything we do.

  5. Risk-Based Validation Of SaaS Solutions: Points To Consider

    This paper looks at validation of Software-as-a-Service (SaaS) solutions and provides relevant points to consider when developing a risk-based approach to validation.

  6. Top Five Reasons You Need IRT Expertise (Not Just Software)

    How IRT vendor relationships can ensure high quality builds that meet pharma companies' needs and avoid the potential pitfalls associated with RTSM.

  7. 3 Challenges Clinical Trial Managers Face

    How to address the unique challenges of finding the right balance between drug overage and outage, ensuring every patient receives the right medication when they need it, and managing clinical trial supply.

  8. Evolution Of Parkinson’s Disease Trial Characteristics: 2005 - 2017

    A longitudinal analysis of PD study characteristics provides a deeper understanding of clinical trials dynamics and demonstrate how research paradigms have been changing across the years.

  9. Central Laboratory Interlaboratory Comparison Program To Assess The Comparability Of Data Of Tests From Four Regional Laboratories Involved In Global Clinical Trials

    The objective of this study was to develop and support a process for assessing the comparability of data used in global clinical trials from four individual laboratories, wholly owned by the same central laboratory entity, and that the same tests on the same samples are under statistical control and acceptable limits of variation.

  10. The Promise And Challenge Of Adaptive Design In Oncology Trials

    Clinical oncology trials are more complex and time consuming than those in any other therapeutic area and failure rates are frustratingly high. Given the urgent need for new oncologic therapies, sponsors are eager to find more effective ways to conduct clinical research.