The Missing Link: Why Study Design Makes or Breaks a Clinical Trial

The Missing Link: Why Study Design Makes or Breaks a Clinical Trial

In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Farrell Healion, Founder and Principal Consultant at OptiTrial, to explore why study design is so often the overlooked "missing link" in clinical development and where real flexibility and patient centricity live. Together, they unpack the gap between what a protocol asks for and how it gets delivered, the trouble with arbitrary First Patient In (FPI) dates and the timeline pressure that forces teams to cut corners, and the creep of unnecessary measures and patient burden that undermines data quality. They also dig into smarter, more patient-centric approaches, from item libraries and computer adaptive testing to disease-specific instrument selection, and the hidden risks of the "copy-and-paste" protocol.

Are We Sacrificing Good for Perfect in Clinical Outcome Assessment?

In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Stacie Hudgens, Chief Scientific and Strategy Officer at Clinical Outcome Solutions, to discuss whether the field of clinical outcome assessment has started sacrificing “good for perfect.” Together, they explore the role of regulatory guidance and clinical development timelines, specifically the role of measurement science in already tight development timelines, when to modify a legacy instrument versus build something new, and why getting measurement scientists involved early is the key to a successful COA strategy.

More Than an Aspiration: Building a Patient-Centric Evidence Strategy That Lasts

In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Lina Eliasson PhD CPsycho, Founding Partner at Sprout Health Solutions, to discuss how pharma companies of all sizes can build a comprehensive, patient-centric evidence strategy that spans the entire drug development pathway. Together, they examine the growing role of COA and in-study interviews in regulatory decision-making, the practical barriers to earlier patient engagement. They explore how eCOA providers could add greater value by getting involved long before a pivotal trial, and a focus on why the choice of data capture modality matters far more than the industry currently recognizes.

Building Fit-for-Purpose PRO Instruments: Focused Modern Measures Over General Instruments

In this episode of LifeSci Talks, Mark Wade, Global Practice Leader & COA SME at TransPerfect Life Sciences, is joined by Katja Rudell, VP of Patient-Centered Outcomes at Kielo Research, to take a behind-the-scenes look at the reality of patient-centered instrument development. They discuss diaries and quality of life tools, rare disease challenges, and proxy reporting, as well as the tradeoffs that can often occur in balancing regulatory rigor, patient burden, and realistic instrument usability. Listen in to hear why multiple instruments for the same disease can often create not only frustration for patients, but can also overburden them simultaneously. The episode will share suggestions as to how study teams can design smarter, more patient-centered measurement strategies.

Meaningful patient involvement in HTA decision making: where do we go from here?

In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Alice Biggane, Outcomes Innovation and Research Lead at Pfizer UK, to discuss how various PRO measures inform and impact reimbursement decisions for HTA driven markets.  Together they unpack what data sources and methods exist for the quantification and understanding of HRQoL for cost-effectiveness decision making and the complex interplay between the need to reduce burden and increase transparency through standardization, while maintaining the crucial and nuanced balance of different stakeholder requirements. Tune in to learn how leading organizations are working to build more inclusive, efficient, and patient-focused clinical trials, and accelerating patient-access to new health technologies.