October 4th 2024
CRO-sponsor relationships are key as industry moves towards new age of outsourcing.
June 7th 2024
With investors embracing the new regulations, a look at the progress CROs are making in their sustainability efforts
May 3rd 2024
Why constant communication and transparency are paramount to successful partnerships between pharmaceutical companies and CROs
April 9th 2024
Improving the site-sponsor relationship can get trials off on the right foot and on a path for success.
January 19th 2024
With variation in costs between different stakeholders in clinical trials, there is often disagreement on fair market value.
CROs Rise to COVID Pandemic Challenges
Industry must take advantage of "lessons learned."
Accelerating Innovation Adoption to Support Drug Development Operations
Characterizing the long-term adoption experience of clinical technologies and capabilities—and what senior leaders can do to drive adoption within their walls.
Clarifying Ownership of Clinical Trial IRT Data: Site vs. Sponsor
Stakeholders from across the industry must discuss ownership to ensure effective implementation.
Getting the Most From FSP Model
Examining best practices in using the functional service provider model for clinical operations, pharmacovigilance, regulatory, and other areas.
Biopharma-Academic Collaborations in 2021
Proactive, pervasive, and strategic planning lead industry into future.
Taking DCTs to the Next Level
In this interview, Dave Hanaman, co-founder, president and chief commercial operator at Curavit Clinical Research discusses launching the organization at the start of the pandemic and how it operates with a commitment to designing trials with a fully virtual site.
Building Relationships Key for Smaller Sponsors
Strong collaboration critical as trial development advances.
The Post-Pandemic CRO Landscape
Technology, talent and specialization add up to a plethora of industry M&As.
Could Technology Supplant CROs?
A move back to in-house management of clinops could be on the horizon for sponsors.
The Tangled Web of Large Outsourced Providers
A brief look at the market for mergers and acquisitions since the year of COVID.
Turnover for Clinical Monitoring Remains High
New BDO CRO Insights Report reveals high rate of CRA turnover and what organizations are doing to combat it.
Providing Greater Opportunity for Undersized CROs
Steven Bukvic, CEO of the ACROSS Global Alliance, speaks to Applied Clinical Trials about how it works to improve the clinical trial experience for smaller- and medium-sized sponsors.
Anticipating Digital Transformation of the Drug Development Workforce
The drug development sector is embracing technologies and digital methods that were previously not as widely used due to the COVID-19 global health crisis.
Legal Perspectives on Conducting Clinical Trials During COVID-19 Outbreak in Malaysia
Nearing a year into the pandemic, this article describes the legal concerns CRM encountered during the COVID-19 outbreak.
Rate of Patient Recruitment to International Multicenter Clinical Studies in Eastern Europe Countries
The success of a clinical study depends on the possibilities to involve the patient in the study.
Early Vaccine Authorization Raises Ethical and Logistical Challenges for Trial Sponsors
FDA’s Vaccines and Related Biological Products Advisory Committee addresses issues related to testing and approval of potential COVID vaccines.
COVID-19 and Its Impact on the Future of Clinical Trial Execution
Findings from a Tufts study examining the effects of COVID-19 on clinical trials.
Addressing the Needs of Clinical Trial Sites in a Post-COVID-19 World
Recognizing pre-pandemic pain points, such as patient engagement and protocol development, could lead to post-pandemic trial success.
Shifting Perspectives on Site Networks to Create Positive Change
Evaluating the lessons learned about trial sites from COVID-19 to form new strategies and improve patient safety for the future.
Key Cost Drivers in Clinical Research: Guide to Successful Budgeting
It's almost impossible to map out study budgets with absolute precision. Planning for the unexpected costs, such as those associated with slow enrollment, protocol amendments, and other contingencies—is vital.
Clear Scope of Work Specifications Makes for Strong CRO/Sponsor Partnerships
To optimize the Sponsor/CRO relationship, the final proposal must represent a win for both parties.
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.
A Journey: Biotech, FDA, and Safety Committee Responses to COVID
Sudarshan Hebbar, CMO of CalciMedica, reveals how the FDA, ethics committees, and safety consortia have responded to helping to advance the application of novel therapeutics towards COVID.
The Rise of FSP Outsourcing in Drug Development
Industry experts share their thoughts on the evolution of the functional service provider model, as demand for flexible resourcing grows.
Small Biopharma and CROs: Seeking Stronger Synergies
Stakes are high for emerging biopharmaceutical companies to get their relationships with CRO partners right from the outset.
How Does FSP Models Complement eSource Implementation?
Biometric functional services, more than any other, can have a significant impact through the standardization of data collection and management.
A Competency-Based Approach to Combating the Talent Wars in BioPharma
Creative approaches are needed to address the clinical research workforce “talent wars”
Clinical Trials Salary and Satisfaction Survey, January 2020
New Research Emerges to Challenge Steep Costs of Clinical Trials
The Institute for Safe Medication Practices has released a new study which breaks down the estimated costs associated with the approval of new pharmaceutical treatments.
CRO Oversight Roundtable
Excerpts resulting from the extended discussion on CRO oversight at the recent CBI Finance and Accounting for Bioscience Companies conference.