Oracle Health Sciences

https://www.appliedclinicaltrialsonline.com/act_w/studies

The way clinical trials are conducted in the European Union (EU) will undergo a major change when 

 comes into effect in January 2022. This new regulation is binding across all member states.

Intrinsic to the new regulation is the simplification of procedures – with only one submission required vs. up to 31 under the old directive – which are streamlined to remove duplication and delays in launching new clinical studies, the introduction of a lighter regulatory regime for trials conducted with medicines that have already been authorized, and the simplification of reporting requirements.

But just being compliant with the regulation should not be considered enough for any forward-looking organization. The regulation provides sponsors and CROs alike with opportunity to rethink how technology plays an important part in bringing efficiencies to clinical trials, by reducing failures and driving operational changes beyond compliance.

The shortcomings of the 2001/20/EC Directive and how this impacted clinical trials being conducted in EU countries.

The intended purpose of EU 536/2014, and the main changes coming into effect.

What organizations stand to gain from adopting the updated regulation, versus the compliance and other costs they’re likely to incur.

Challenges and potential impediments to the attractiveness of the EU 536/2014 for the conduct of early-phase studies.

How harmonization and standardization of submissions provides an opportunity to reduce failures and drive operational changes beyond compliance, by increasing predictability during country selection.

How technology can help both in the tracking, and reporting of submissions, and in proactive planning based on machine learning.

Sponsor and CRO roles who are responsible for:

Country and site identification, feasibility assessment, selection, and activation

Clinical data management, collecting and evaluating trial metrics

Project management of studies, process optimization, and operational excellence


Head, Operational Design Center
EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany


Executive Director Regulatory Affairs, PPD
ACRO committee member


Pharmaceutical Consultant & formerly Senior Director, Clinical Development Operations
Daiichi Sankyo, Inc


Director, Industry Strategy
Oracle Health Sciences

Webcasts

The way clinical trials are conducted in the European Union will undergo a major change when (EU) No 536/2014 comes into effect in January 2022. But just being compliant with the regulation should not be considered enough – forward-looking organizations are rethinking how technology can play an important part in bringing efficiencies to clinical trials, by reducing failures and driving operational changes beyond compliance.

 New EU (536/2014) Clinical Trial Regulation Set to Attract More Studies and Innovation

https://www.appliedclinicaltrialsonline.com/act_w/impact

The COVID-19 pandemic radically changed the world in an instant and forced adaption across the board. In the Life Sciences industry, those conducting clinical trials had to quickly adjust to support new ways of monitoring and caring for clinical trial participants in a world where physical access was not an option.

As we look toward a post-pandemic world, Oracle , in partnership with Informa Pharma Intelligence conducted a global, industry-wide survey to understand the adaptations that were made to clinical trials during the pandemic, the effect of these adaptations, and the impact of these changes on the future of clinical trials.

The research forecasts the continuation, as well as discontinuation, of certain approaches such as EHR, eSource, ePro, and patient apps – and the impact of these approaches on clinical trial data, quality , and speed. It will also shed light on the industry’s level of confidence in the data generated from these new clinical trial approaches, in comparison to data collected via pre-pandemic methods, and other expectations as we step forward into the post-pandemic world.



Join this webinar to also understand if your peers:

View the impact of the changes made during the pandemic as positive or negative

Plan to increase or decrease their use of DCT, hybrid, and fit-for-purpose clinical trial models

Plan to give patients the option to choose how they participate in clinical trial


Director, VP level, and Executive Management

Professionals seeking further knowledge on how to develop their digital strategy for clinical trials

Kristin Letourneau
PhD - Director of Market Research
Informa Engage

Jim Streeter
Global Vice President Life Science Customer Success
Oracle Health Sciences



: Tuesday, October 26, 2021 at 11 EDT | 8am PDT | 5pm CEST | 4pm BST

On demand available after final airing until Oct. 26, 2022



***Live: Tuesday, October 26, 2021 at 11 EDT | 8am PDT | 5pm CEST | 4pm BST*** Oracle Health Sciences reveals new research conducted to understand the technology adaptations that were made to clinical trials during the pandemic, the effect of these adaptations, and the impact of these changes on the future of clinical trials.




2021 Research: The Impact of New Clinical Trial Approaches Adopted During Pandemic

http://www.pharmexec.com/pe_w/bottom_line

Managing clinical trials is challenging and fraught with pressure to adhere to timelines and keep costs down. Too often, emerging pharma and biotech companies do not have the time or resources to research and implement innovative technology to efficiently conduct clinical trials. In turn, they default to what they’ve used previously, or rely solely on their CROs to establish process. In either scenario, they may be missing a significant opportunity to drastically improve trial timelines and reduce trial costs. Understanding the technology landscape, and working as educated partners with CROs, they can help determine the most effective, fit-for-purpose solution and reduce the heavy burden of multiple systems with limited capabilities and insight.

Join this webinar to see how small to medium sized companies can benefit from a unified platform, with lessons learned from Michele Taylor-Scott, Head of Data Management at Health Decisions, a specialty CRO focused on women’s health and diagnostics. Michele will share how a shift in their technology environment has allowed her to build a full study in a matter of weeks, and easily execute mid-study and post-production changes in real-time allowing her to reduce the overall time it takes for her customers to bring a drug to market.

Understand your options for clinical trial management and how to dramatically improve timelines and costs

See how Health Decisions is efficiently managing clinical trials by leveraging a user-friendly, intuitive and scalable solution

Learn how you can quickly and easily make changes to your study in real-time, without the traditional delays and system complexity

 Michele Taylor-Scott, Head of Data Management, Health Decisions

Michael McGloughlin, Sales Director, Emerging Biopharma, Oracle Health Sciences

Bill DeSousa, Master Principal Solution Consultant, Oracle Health Sciences

: Tuesday, Oct. 20, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after final airing until Oct. 20, 2021

***Live: Tuesday, Oct. 20, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST*** Join Oracle Health Sciences and Michele Taylor-Scott, Head of Data Management at Health Decisions as they discuss why it is important for small to medium sized pharma and biotechs need to understand the technology landscape in order to work as educated partners with their CROs to help determine the most effective, fit-for-purpose solution for their clinical trials. 
Learn how a unified platform can help build a full study in a matter of weeks and reduce the overall time it takes to bring a drug to market. ***On demand available after final airing until Oct. 20, 2021***

Oracle Health Sciences

Articles

New EU (536/2014) Clinical Trial Regulation Set to Attract More Studies and Innovation

2021 Research: The Impact of New Clinical Trial Approaches Adopted During Pandemic

How to Work with Your CRO to Significantly Improve Clinical Trial Management and the Bottom Line