COVID-19Lessons Learned

A ‘Holy Grail Moment’ for Clinical Research

November 23, 2020 0 Comments

It was a familiar scenario: A rare disease area of oncology. A new drug candidate. A desire to assess efficacy as safely and quickly as possible, so that if successful, a new therapy could get approved and change lives. But this desire could have been tempered by reality: the trial was going to be challenging and slow…

COVID-19Lessons Learned

Seeing progress through the eyes of patients

November 20, 2020 0 Comments

For the clinical research industry, technological tools improve trial continuity, and generate data that helps power more robust monitoring of safety and quality. They can also be a natural fit for patients. IQVIA also sees study participants liking the direct shipment of medicines, telehealth interactions and at-home visits. In the COVID era and beyond, designing more trials with these kinds of technology-enabled strategies is going to help more people by lowering barriers to participation, and speeding the development of new medicines.

COVID-19Lessons Learned

Are we ready for holistic, virtual access?

November 18, 2020 0 Comments

Diverse technology solutions, like patient telehealth visits, accessing electronic medical records (EMRs) or remote source data verification, can generate vast amounts of data. As the clinical research industry evolves towards its next “new normal” with a higher baseline level of remote monitoring, IQVIA is considering the implications of increasing data access. Are we ready?

COVID-19Lessons Learned

Technology solutions: Weathering a storm, helping envision a future

November 16, 2020 0 Comments

We all had a flurry of unprecedented activity. We were assessing risks to patients and data, and putting in place mitigation strategies to preserve continuity of the studies.” Those strategies involved thousands of amendments to protocols, adapting to sudden changes that impacted patients and sites around the world.

COVID-19Lessons Learned

A new fight sees new tools and new challenges

November 2, 2020

A key pillar in the COVID-19 battle is the rapid development of a safe and effective vaccine. As vaccine R&D shifted into gear and then accelerated throughout 2020, with a rapidly growing number of candidates, platforms and manufacturers, it appeared that a bottleneck in this race could actually be the ability to enroll participants.

COVID-19Lessons Learned

When technology may be the easy part

October 26, 2020

In the 10 weeks following the US’ declaration of a pandemic crisis, hospital ER visits declined for conditions like heart attacks and strokes. Simultaneously, based on clinical trials in the Medidata ecosystem, new subject enrollment declined 30%. But also in that time period, ER visits related to uncontrolled high blood sugar saw less of a decline. Patients continued to seek care. Why?

COVID-19Lessons Learned

A global sense of urgency: Collaborating to advance the conduct of clinical trials

October 23, 2020

“There’s a global sense of urgency,” says Jamie Macdonald, CEO of Parexel, of the collaboration between stakeholders to accelerate development. One key focus for Macdonald is the lengthy process of trials, and compressing that “dead space” to shorten timelines, improve efficiency and quality.

COVID-19Lessons Learned

The need for new paradigms

October 21, 2020

“The pandemic has changed everything about the pace of our innovation and our focus,” says Peyton Howell, EVP and Chief Commercial & Strategy Officer at Parexel. There used to be lots of caution around using real-world data and evidence, but this year has illustrated the need for new paradigms.

COVID-19Lessons Learned

A Catalyst for Innovation, Urgency for Now, Momentum for the Future

October 19, 2020

For Dr. Sy Pretorius, Parexel’s Chief Medical & Scientific Officer, COVID-19 has been a catalyst. The pandemic has accelerated innovations that make it easier for patients to participate and for sponsors to conduct research. Parexel has seen increases in decentralized trials and remote monitoring, where study designs were adapted amidst the pandemic.

Lessons Learned

Sharpening the pencil: Rethinking trial design with the patient at the center

October 15, 2020

New medicines are at the core of clinical research. Historically in clinical research, these experimental medicines move from a warehouse to a…

Lessons Learned

Patient engagement, thinking ahead and how the clinical research industry helps solve global problems: A conversation with Alistair Macdonald – Part 2

October 9, 2020

In August 2020, Syneos Health CEO Alistair Macdonald reflected on the COVID-19 crisis to date. Read Part 1 of the conversation. In…

Lessons Learned

Clinical Research in the COVID Era: Learning Lessons, Saving Lives

September 29, 2020

Doug Peddicord, ACRO’s Executive Director, introduces the series and sheds light on the importance of CROs and technology companies in spearheading clinical innovation through COVID-19 and beyond.

Lessons Learned

COVID, the role of digital, and the future of clinical research: A conversation with Alistair Macdonald – Part 1

September 29, 2020

In August 2020, Syneos Health CEO and ACRO Board Chair Alistair Macdonald reflected on the COVID-19 crisis to date. This conversation has been edited lightly for clarity.

Press Releases

New ACRO Report Introduces Quality-by-Design, Risk-Based Framework for Decentralizing Clinical Trials

September 1, 2020

September 1, 2020 – (Washington, DC) – Clinical trial activities have traditionally centered around trial sites where patients travel for participation. This…

NewsPress Releases

ACRO Members Heed the UK Government’s Call for Volunteers in Response to the COVID-19 Pandemic

May 6, 2020

May 6, 2020 – (Washington, DC) – In an effort to fight the global COVID-19 pandemic, over 150 employees from clinical research…

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News

2020 Officers and New Member Announcement

December 17, 2019

Washington DC – The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected Alistair…

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News

ACRO hosts Congressional Briefing on clinical research advancements

October 24, 2019

On Wednesday, October 23, 2019, ACRO hosted a Congressional Briefing on Capitol Hill. With the help of the Congressional Research & Development…

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NewsReports

A Consistent Approach to Risk Based Quality Management: Collaboration is Key

October 24, 2019

Developing, executing and overseeing clinical trials is a complex process. Yet it is essential to gain reliable evidence from clinical trials to…

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NewsReports

New ACRO Report Quantifies Benefits of RBM for Quality Reviews

October 17, 2019

A new report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient…

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News

Advancing the Adoption of Risk-Based Monitoring Strategies in Clinical Trials

August 16, 2019

On July 17, 2019, under cooperative agreement with the FDA, the Duke-Margolis Center for Health Policy (Duke Margolis) held a public workshop. The event, titled Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations, aimed to identify opportunities to improve Risk Based Monitoring (RBM) implementation and solicit stakeholder input on the challenges, barriers, and enablers that impact the successful adoption of RBM.