Impactful Collaborations Drive Technology and Standards Adoption in Outsourced Studies

Susan Jalbert
Director, Alliances & Channels

When the Association of Clinical Research Organizations (ACRO) announced the expansion of its membership to include technology leaders in clinical research, Oracle Health Sciences was excited to join the discussion on how clinical research organizations (CROs) and technology providers can better work together to improve the clinical trial process.

The world of clinical research is rapidly changing. Technology is propelling clinical trials into a new era of scientific breakthroughs in the industry. As new technologies emerge and define what is possible, CROs are embracing innovation. As a result, the pace of change in the CRO industry is increasing, and CROs are treading into new waters for safe, ethical, high-quality medical research for patients to benefit from the development of new treatments and therapies — underscoring the importance of collaboration. ACRO provides the needed forum for leading CROs to collaborate and discuss this rapidly changing world of technology, regulatory requirements /guidance and industry standards in clinical research.

ACRO is a leading voice for safe and ethical clinical trials, working with stakeholders globally to promote a better and more efficient clinical trial process. ACRO supports its members by advocating on behalf of these companies to biopharma and medical device companies, regulators, legislators, peer associations, academic organizations, patient groups, the media and the public. ACRO is dedicated to bringing efficiency, innovation and value to the clinical research process and to highlighting the important contribution that clinical research and technology companies make as partners in the development of new medicines and new treatments that benefit millions of patients worldwide.

With the global impact ACRO has on the industry and their collaboration with regulators, sponsor, and policy makers in clinical research and now technology providers this will help create dynamic business environments to help its members succeed.

With the advent of the ICH E6 (R2) addendum, EU regulation 536/2014, MHRA guidance on contemporaneous and other recent regulatory changes, quality, oversight and risk management are spotlight areas of interest for pharmaceutical and biotech companies and their outsourcing CRO partners. Both Oracle Health Sciences and ACRO are focused on providing relevant leading practices to ensure these issues are addressed head-on by proactive planning into the initiation of clinical trials in order to stem downstream organizational non-compliance and related issues which can derail a study.

Oracle Health Sciences collaborates with its clients and partners globally and welcomes this opportunity to participate with ARCO to contribute to the dialog on how innovative technologies can advance clinical research processes and outcomes and help its members achieve more patient centric trials. As an active member of ACRO, Oracle Health Sciences is now working with industry leading CROs on numerous initiatives, such as EMA/MHRA TMF expectations.

Learn more about ACRO

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Comments ( 1 )
  • Elvin Thalund Thursday, January 30, 2020
    I really existed to represent Oracle at ACRO in the TMF team, which have already led to this webinar "The Importance of Contemporariness and an Approach to Mitigate Audit Findings"

    This work will hopefully lead to some regulatory #MHRA, #ICH, #FDA changes/clarification related to TMF contemporariness, draft documents, audit trail requirements... and ultimately lead to better integration #ClinicalOne of operational and regulatory systems, to serve all involved parties and the need of #RiskBasedManagement and #AdaptiveTrialDesign
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