Authors
Latest:
Navigating eConsent Submissions: Who, What, Where, and Why?Unraveling eConsent Ethics Committees and Health Authorities submission document requirements to foster wider adoption.
Latest:
Creating an Integrated Digital Pathway for Sites and Sponsors*** Thursday, June 17, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST *** Join this webinar to hear best practices on how to enhance site-sponsor collaboration, compound efficiencies and accelerate trials by enabling end-to-end document exchange between sponsor eTMF systems and Florence’s leading eISF solution through Cognizant SIP. ***On demand available after final airing until June 17, 2022***
Latest:
AI in Clinical Trials: The Future of Drug DiscoveryDespite the significance offered by AI to pharmaceutical companies, there are several challenges that must be overcome for successful integration of tech-based tools.
Latest:
Awareness of Clinical Research Increases Among Underrepresented GroupsLatest CISCRP study provides insight on proactive outreach.
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:
Exclusivity or Collaboration in Clinical Trials - What's the Best Formula for Success?*** Monday, May 24, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST *** Most organizations deal with the vulnerabilities that exclusive point solutions create. Join industry leaders Oracle and IQVIA to understand how inclusivity and a flexible environment can help you employ new approaches faster, and the benefits of collaboration in today’s clinical trials ecosystem.*** On demand available after final airing until May 24, 2022 ***
Latest:
The Regulatory Requirements and Key Points of Drug Clinical Trials Registration in ChinaFollowing the implement of new Drug Registration Regulation in July 2020, the clinical trial registration system will have some major changes in China.
Latest:
How Remote Patient Monitoring Technology Can Impact Decentralized Clinical TrialsWhat is next for DCTs after acceleration from COVID-19?
Latest:
The Transformation of Clinical Trials from Writing on Papyrus to the World of TechnologyNew requirements must be put in place to ensure data quality and integrity.
Latest:
Regulatory Considerations Surrounding Human Challenge Studies with the SARS-CoV-2 VirusA first vaccine against this coronavirus could still take some time to develop, but mRNA vaccine platforms could offer an early breakthrough.
Latest:
4 Key Actions ClinOps Can Take Now to Avoid DisruptionsBiopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.
Latest:
Introducing PALADINFirst-of-its-kind consortium dedicated to accelerating new medicines development through optimizing patient advocacy group—industry collaboration.
Latest:
Clinical Research Needs Greater Participant DiversityCOVID spotlights the troubling disparity in clinical research representation. How can we remove these barriers?
Latest:
Clinical Trial Disclosure and Data Transparency: Obligation or Opportunity?Implementing disclosure and data transparency policies and procedures represents an opportunity for sponsors, rather than an obligation.
Latest:
Rapid and Scalable Real-World Evidence Generation with Study Automation PlatformsSonja Wustrack, OM1, highlights a new clinical study automation platform to support critical data collection and real-world evidence.
Latest:
Augmenting Single Arm Oncology and Rare Disease Trials with Real World EvidenceRWE can augment, extend, or enrich the findings from clinical trials to provide valuable evidence to support the development programs for product approvals.
Latest:
Understanding the Complexities of Diversifying Clinical TrialsTufts Center for the Study of Drug Development and Biogen recently conducted a study to inform growing interest in improving diversity of clinical trial participation. The results of this research provide insights into increasing the community of minority investigators and study staff and presenting greater access to clinical trials among minority study volunteers.
Latest:
The Rise of Gene Therapy: Advanced Regulatory, Site, and Enrollment ConsiderationsDeveloping new pathways to overcome study-related challenges is key to realizing the promise of the latest gene therapies.
Latest:
A Biosafety Perspective on Operational Challenges in Cell and Gene Therapy StudiesThe benefits of working with an institutional biosafety committee in CGT research.
Latest:
Leveraging Data Insights to Address the Perils of Linear Practices in Site Identification and ActivationPhesi and Tufts CSDD share results from research on operating practices that can be improved.
Latest:
Executing Trial Design With Patients—Not For PatientsApproaching protocol design and operational planning with patient empathy.
Latest:
Clinical Trials and TrustUnderstanding the role of social determinants on clinical trial participation and trust.
Latest:
Virtual Medical Affairs Audits: A Viable AlternativeVirtual audits proving to be beneficial post-COVID despite continuing challenges.
Latest:
Clinical Trials in Indonesia: Challenges and Opportunities for Industry SponsorsImproved diversity in clinical trials can be achieved by exploring opportunities for research in developing countries that have not historically participated in large-scale, industry-sponsored clinical trials.
Latest:
Introducing PALADINFirst-of-its-kind consortium dedicated to accelerating new medicines development through optimizing patient advocacy group—industry collaboration.
Latest:
Patients Are at the Heart of Cell and Gene TherapyIf you are an organization content with patient-centric approaches, you are behind. Today it is about patient-driven drug development.
Latest:
The ICR-CRM-IQVIA Research Network Collaboration ExperienceA discussion of the impact of a strategic alliance in to facilitate operational success at the clinical trial site level in Malaysia.
