Authors
Latest:
Changing the Paradigm in AI ImplementationHow pharma companies can reduce the risk of failure with AI-based innovations.
Latest:
FDA’s New Diversity Plan Guidance, And What It Means for Sponsors Developing Cancer DrugsGuidance will compel sponsors to consider new enrollment strategies and to be more diverse.
Latest:
Community Pharmacies Can Help Bridge the Diversity GapThrough grassroots patient education, local pharmacies serve as a pivotal doorway to improving access to trials.
Latest:
FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug DevelopersJanuary 2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus.
Latest:
Clinical Trials and TrustUnderstanding the role of social determinants on clinical trial participation and trust.
Latest:
Establishing Metrics and Standardization for Non-CRF Data in EDCWhile Case Report Forms are a main contributor to collected data, non-CRF data such as core laboratory data and central imaging can be critical to any clinical study.
Latest:
Data Integration Strategy: The Cornerstone Of A Successful Regulatory SubmissionThe data, not the plan, provide the direction.
Latest:
Direct-to-Patient: At-Home Clinical Trials Are Here to StayThe success of the decentralized model hinges on coordination between stakeholders across the supply chain to ensure that date is secure, medication is delivered on time, and in proper condition.
Latest:
Prioritizing Patients: Strategies and eCOA Best Practices in Drug DevelopmentA more user-centered design can allow increased flexibility in the development of eCOA platforms, driving better engagement and participation.
Latest:
Changing the Digital Health Playing Field: A New EraMoving beyond the pill to extend the value being delivered to patients.
Latest:
Data Collection in Clinical Trials with Multiple CaregiversThe conundrum of missing data vs. inter-rater variability.
Latest:
Increased Digitization in Clinical Trials: Expectations for the Year AheadTop predictions for the major trends that will shape clinical trial design in 2022.
Latest:
Early Protocol Assessment for Increased Patient CentricityHow novel clinical trial designs can help minimize patient burden.
Latest:
The Value of Clinical Trial Liaisons in the Drug Development LifecycleClinical trial liaisons rather serve as experts in their therapeutic areas and as clinical trial specialists to provide a suite of strategic advantages to benefit a study.
Latest:
Harnessing Unstructured Data and Hospital InteroperabilityThe potential of next-generation platforms in transforming patient recruitment.
Latest:
Compliance Amid the ‘Great Resignation’Minimizing impacts through focus on employee wellness.
Latest:
Four Key Trends for Identifying Regulator and Payer Evidence Needs in Oncology Drug DevelopmentHow to leverage novel trial designs and real-world data to support a cancer drug submission with an evidence strategy that is both approvable and reimbursable.
Latest:
Rate of Patient Recruitment to International Multicenter Clinical Studies in Eastern Europe CountriesThe success of a clinical study depends on the possibilities to involve the patient in the study.
Latest:
Getting the Most From FSP ModelExamining best practices in using the functional service provider model for clinical operations, pharmacovigilance, regulatory, and other areas.
Latest:
Getting to Clinical Trial DiversityDiffering levels of trust in clinical trials information channels across diverse populations is examined in this research.
Latest:
How to Determine ‘Good Science’ for Systematic Literature Reviews in Clinical Research and DevelopmentBest practices for assessing publications.
Latest:
Currency of Patient Engagement: Changing TidesMeeting patients at the point of care can increase trust and engagement.
Latest:
Identify Opportunities to Improve Diversity RecruitmentWhile it's important to note that there are areas where the industry can improve, there are unique opportunities of improvement for specific types of sites and the number of studies conducted there.
Latest:
Real-World Use of an Artificial Intelligence-Supported Solution for Coding of Adverse Events in Clinical TrialsStudy evaluates the use of AI-supported medical coding module.
Latest:
Engaging Patients With Behavioral Science and Patient-centered TechnologyEvolving mindsets are opening the door for industry to utilize new mediums for understanding patients.
Latest:
The Future Fit of Wearables for Patient-Centric Clinical TrialsHarnessing these tools for successful integration and streamlining of processes.
Latest:
The Current Status of European Research Related to COVID-19: The EUCROF PerspectiveSuccessful collaborations between Pharma/Biotech/Device industries and CROs will play a key role in an effective fight against the global COVID-19 pandemic.
