Authors



Oracle Health Services

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 ***


Zhuxing Yao

Latest:

The Regulatory Requirements and Key Points of Drug Clinical Trials Registration in China

Following the implement of new Drug Registration Regulation in July 2020, the clinical trial registration system will have some major changes in China.


Tony Fantana

Latest:

How Remote Patient Monitoring Technology Can Impact Decentralized Clinical Trials

What is next for DCTs after acceleration from COVID-19?


Luis A. Rojas, PhD

Latest:

The Transformation of Clinical Trials from Writing on Papyrus to the World of Technology

New requirements must be put in place to ensure data quality and integrity.


Robin Rogiers

Latest:

Regulatory Considerations Surrounding Human Challenge Studies with the SARS-CoV-2 Virus

A first vaccine against this coronavirus could still take some time to develop, but mRNA vaccine platforms could offer an early breakthrough.


Ronald Du

Latest:

4 Key Actions ClinOps Can Take Now to Avoid Disruptions

Biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.


Abigail Dirks

Latest:

Introducing PALADIN

First-of-its-kind consortium dedicated to accelerating new medicines development through optimizing patient advocacy group—industry collaboration.


Perla Nunes

Latest:

Clinical Research Needs Greater Participant Diversity

COVID spotlights the troubling disparity in clinical research representation. How can we remove these barriers?




Massimo Zaninelli

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.


OM1

Latest:

Rapid and Scalable Real-World Evidence Generation with Study Automation Platforms

Sonja Wustrack, OM1, highlights a new clinical study automation platform to support critical data collection and real-world evidence.


Jennifer Christian, PhD

Latest:

Augmenting Single Arm Oncology and Rare Disease Trials with Real World Evidence

RWE can augment, extend, or enrich the findings from clinical trials to provide valuable evidence to support the development programs for product approvals.


Kate Wilson

Latest:

Understanding the Complexities of Diversifying Clinical Trials

Tufts 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.


Naomi Kautz

Latest:

The Rise of Gene Therapy: Advanced Regulatory, Site, and Enrollment Considerations

Developing new pathways to overcome study-related challenges is key to realizing the promise of the latest gene therapies.


Daniel Kavanagh, PhD, RAC

Latest:

A Biosafety Perspective on Operational Challenges in Cell and Gene Therapy Studies

The benefits of working with an institutional biosafety committee in CGT research.


Zak Smith

Latest:

Leveraging Data Insights to Address the Perils of Linear Practices in Site Identification and Activation

Phesi and Tufts CSDD share results from research on operating practices that can be improved.


Shana Hull

Latest:

Executing Trial Design With Patients—Not For Patients

Approaching protocol design and operational planning with patient empathy.


Juliana Ison

Latest:

Clinical Trials and Trust

Understanding the role of social determinants on clinical trial participation and trust.


Denise Dixon

Latest:

Virtual Medical Affairs Audits: A Viable Alternative

Virtual audits proving to be beneficial post-COVID despite continuing challenges.


Lena Low; Martin Lim; Terttu Haring; Serena Chan; David Gebbo; Lucia Rizka Andalucia; Roy Himawan; Indri Rooslamiati; Dona Arlinda

Latest:

Clinical Trials in Indonesia: Challenges and Opportunities for Industry Sponsors

Improved 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.


Lisa LaLuna

Latest:

Introducing PALADIN

First-of-its-kind consortium dedicated to accelerating new medicines development through optimizing patient advocacy group—industry collaboration.



Susan Brisendine

Latest:

Patients Are at the Heart of Cell and Gene Therapy

If you are an organization content with patient-centric approaches, you are behind. Today it is about patient-driven drug development.


Robert Kerle

Latest:

The ICR-CRM-IQVIA Research Network Collaboration Experience

A discussion of the impact of a strategic alliance in to facilitate operational success at the clinical trial site level in Malaysia.


Ruby Madison Ford

Latest:

Assessing Sponsor Attitudes Toward Retail Pharmacy Involvement in Clinical Trial Recruitment and Execution

Amid CVS’ surprise exit from the clinical research space and the ensuing broader questions, study investigates the benefits of pharmacy chain involvement—along with the concerns and barriers to adoption.


Brian Ongioni

Latest:

Consent Management: Moving Beyond Simple eConsent

Providing patients with more flexibility in how they choose to participate in trials.


Ana Cosme, PhD

Latest:

Consequences of Brexit for Clinical Trials in Europe

Higher costs headline list of new challenges faced by CROs and sponsors.


Donna Hanson

Latest:

Optimizing Patient Recruitment and Engagement Strategies

Five strategies to reduce risk and achieve deadlines.

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