Blogs

House report on Aduhelm approval calls for FDA to clarify its role in advising sponsors on drug testing and submissions.

Gillian Livock, SVP & general manager, customer engagement at Medable and Noolie Gregory, VP of DCT operations at Syneos Health discuss how combining technology with clinical operations delivers better data and clinical trial patient oversight.

Tim Bray, chief sourcing and training officer at Virb discusses how CROs and sponsors can mitigate risks by onboarding CRAs with less experience.

With compliance deadline at end of month, concerns over readiness remain.

How evidence generated by the latest IgniteData ‘real-setting’ pilot study supports the case for clinical trial transformation.

Sam Whitaker, co-founder and co-CEO of Mural Health discusses his time in the industry and patient needs in the current clinical trials market.

Despite agreement on recommendations between European regulators, DCT unclarity remains.

The Consolidated Appropriations Act for 2023 includes dozens of measures involving drug development and regulation.

Michelle Webb, vice president of the WCG Avoca Quality Consortium, discusses her perspectives on FDA's revised overview of inspection activities.

Strong shift to DCTs, regulatory changes, and increased focus on diversity among main industry talking points in 2022.

Kenneth Koblan, PhD, chief scientific officer at Sunovion, discusses novel therapy development and clinical trial challenges in mental health.

Nabil Chehab, medical affairs head of lung cancer franchise at AstraZeneca, discuss strategies used in the Phase III AEGEAN trial for treating non-small lung cancer (NSCLC).

Debates caught between focusing on existing antibiotics and developing new agents.

Looking back on major FDA moves in 2022.

Marci Macpherson, executive director, quality assurance and compliance at Ionis Pharmaceuticals, discusses her perspectives on inspection readiness.

The Sudan Ebola virus outbreak in Uganda spotlights this dilemma in responding to public health crises.

Inaugural group of members added to EMA’s new data network focused on RWE.

New guidance to drill down on more specifics in hopes of harnessing the growth of these types of studies.

Dr. Pratik Darji, Head of Progressive Clinical Research Solutions in Gujarat, India discusses the state of clinical trials in the country.

Following closely contested election, approval of FDA bills most likely tabled until new year.

Rare disease stakeholders speak out ahead of anticipated EU changes.

Despite pandemic setbacks, teams must reconsider overlooking IRT functionality in favor of meeting timelines.

Richard Williams, PhD, chief medical officer at Kinnate Biopharma Inc. discusses clinical trial strategies and challenges.

Sharon Reinhard, VP of quality at AVROBIO, discusses a qualitative perspective on the CRA shortage topic.

Potential drug removal spotlights latest debate over the expedited pathway.

Smoothing path to CTIS compliance will be key in overall effort to transform clinical trials in Europe.

Jill Pellegrino, vice president of recruitment and RWE at CVS Health® Clinical Trial Services discusses the infrastructure of recruiting patients in pharmacy settings and why CVS Health has entered into the world of clinical trials.

Sheri Kuss, clinical quality group lead at Pfizer, discusses the new "culture of quality" in clinical trials.