April 28th 2025
How today’s SSO reduces site burden and spearheads clinical system interoperability.
April 22nd 2025
Strategies for ensuring that innovation with PROs remains parallel with advancements in disease detection and progression.
April 16th 2025
With close collaboration between sponsors, CROs, and regulators, this emerging technology has the potential to greatly improve the lives of patients.
March 24th 2025
Survey from the Site Council gathered insights from its members on the quality of site coordinator work.
March 14th 2025
Addressing data integrity and compliance concerns.
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.
CROs Tackle Neurodegenerative Disease Studies
In this interview, Linda Rawlings, VP of Neurodegenerative Development at Synteract, elaborates on addressing the challenges of neurodegenerative disease clinical trials.
Janssen Advances Efficiency and Effectiveness in CRO Oversight Model
Joe Pollarine, Head of GxP Systems Strategy Director at Janssen, recently spoke about CRO oversight models and will expand on these models in this interview.
The Emergence of the Few: M&A in the CRO Industry
As the size, complexity, duration, cost, and globalization of clinical trials has grown, pharmaceutical and biotech companies have moved to outsource clinical activities to CROs to achieve a wide range of objectives.
Know Before You Go: Japan Trials
There are key cultural differences to be aware of before conducting clinical trials in Japan.
Think Big on Outsourcing: A Network Approach for Small Biopharma
Proposed partnership model explores the value of establishing alliances between CROs and networks of small and emerging biopharma companies.
Implementation and Usage of Data Monitoring Committees
Exploring sourcing model options for appropriate incorporation of DMCs into a clinical program.