Oracle

Articles

Decentralized Clinical Trials and the Adoption of Digital Health into Clinical Research

http://www.appliedclinicaltrialsonline.com/act_w/oversight

As the complexity of clinical trials continues to increase, the importance of CROs to the pharmaceutical industry has increased significantly. Outsourcing allows pharmaceutical companies to utilize on-demand services, improving operational efficiencies by accessing therapeutic expertise and geographic reach. This reflects a sharper focus on core competencies and a shift to allow CROs to manage and conduct clinical trials.

The use of KPIs for ongoing risk management from ICH E6 (R2) creates both opportunities and challenges in the sponsor-CRO collaboration.

However, the forthcoming ICH E8 (R1) and ICH E6 (R3) guidelines focus on Quality by Design (QbD) to gain efficiencies in conducting clinical trials – significantly impacting oversight.

Selection, implementation, and use of KPIs in a sponsor-CRO collaboration.

Challenges associated with metric definitions – what if the CRO’s system doesn’t capture the data? Or if their process is different?

Importance of context in interpreting KPIs.

The often, over-looked human aspect – the benefits of addressing mindset and culture change.

Tools provided by ICH E6 and E8 guidance’s to drive efficiencies in clinical trials.

How organizations can improve their operational efficiencies by adopting automation, standardization, and eliminating unnecessary duplicate processes/technology.

Sponsor and CRO roles who are responsible for:

Clinical data management, collecting and evaluating trial metrics

Project management of studies and operational excellence


Associate Director, Clinical Performance, Global Clinical Development Operations
Jazz Pharmaceuticals


Steve had over a 17-year career with GW Pharma, before it was acquired by Jazz Pharmaceuticals in 2021, where he currently resides – he has spent five years as a CRA, five as a Clinical Project Manager, four managing programs of clinical trials, before moving into the people/tools/processes side of maintaining a global Clin Ops team. He is currently responsible for the frameworks, tools and processes relevant to ‘clinical performance’ within the Global Clinical Development Operations department at Jazz, including the current implementation of a Clinical Trials Metrics/KPI Framework.


Director, Dorricott Metrics & Process Improvement Ltd.

Keith has a background in manufacturing from Kodak Ltd. and has worked in quality, metrics, process improvement and operational roles over 11 years for two major CROs. He is a Master Black Belt in Lean Sigma quality and process improvement techniques and is an expert in root cause analysis developing a novel approach for clinical trials. He speaks regularly at conferences and in webinars on topics from KPIs for oversight to Risk-Based Quality Management. He provides consultancy services and training on KPI selection and use, Risk-Based Quality Management, and root cause analysis. He runs several work groups for the Avoca Quality Consortium.


Director, Industry Strategy
Oracle Health Sciences


Elvin is a recognized industry expert in clinical trials, having over 20 years of experience working as a clinical business analyst consultant at major pharmaceutical companies, including, Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in Oracle Health Sciences effort to optimize Study Startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a master of science in industrial engineering from Aalborg Universitet.

Webcasts

Tuesday, May 24th, 2022 at 1pm EDT|10 am PDT|6pm BST|7pm CEST

Simply handing off multi-million-dollar studies to CROs without carefully crafted plans for communications and reporting operational data as the study unfolds is hardly a wise move, yet what kind of oversight is needed? Technologies that track how studies unfold are essential but putting that information to good use requires turning real-time visibility into actionable data.

Is Oversight a Burden or Pivotal to Operational Efficiency?

http://www.appliedclinicaltrialsonline.com/act_w/critical_insights

Decentralized and hybrid clinical trials changed from a futuristic possibility to a reality overnight. While it has taken time for the industry to digest this fundamental shift, research shows that these new methodologies are here to stay.

Many organizations have yet to figure out how to fit these new methods into their existing ecosystems in a scalable and efficient way. Current eClinical platforms natively lack key digital data capture capabilities, which then necessitates complex third-party integrations, resulting in data redundancy and quality issues.

This webinar will go through the complexities that decentralized and hybrid methodologies bring to first-generation platforms, and how a single, unified platform enables interoperability and flexibility to help truly unlock the potential of these digital study methods.

Understand why hybrid and decentralized trials typically require complex integrations

Learn how to accelerate critical insights through access to data from all sources in real time

See the benefits of a scalable, interoperable unified platform

Director, VP level, and Executive Management

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


Director, Life Sciences Product Strategy
Oracle Health Sciences


Tony is a product Strategist with over 20 years of experience in the pharmaceutical and healthcare industries. He has a Master of Business Administration from The University of Texas at San Antonio. With a broad range of experience in Data Management across Biotech, Pharma and CRO, he has also spent time implementing an MDR solution within numerous research organizations. He is looking to focus his experience to foster advances in the Data Collection space and thereby improve the Clinical Development Lifecycle.


Executive Director Digital Trials Strategy
Oracle Health Sciences

As Oracle’s Executive Director Digital Trials Strategy, David Blackman has responsibility for aligning digital strategies and innovations with Oracle’s developing business needs. Within his role in Oracle’s Health Sciences Global Businesses Unit, David is responsible for creating and developing differentiating technology and business capabilities through development, partnerships and acquisitions that enhance clinical trial research and accelerate bringing drugs to market for our clients.

Before joining Oracle in 2021, he served in the Corporate Development and Strategy group at 

 where he had responsibility for PPDs business innovation, leading and incubated cutting-edge business solutions resulting in the investment, development, integration and commercialization of digital and remote clinical trials capabilities. Prior to that David worked at IBM/Lenovo, where he held a number of global technology and business leadership roles.

A graduate of the University of Johannesburg in South Africa, he combines his more than 20 years of technological experience in development, process and technology innovations with his commitment to implementing cutting-edge technologies as a platform that advance innovative technology solutions in clinical trials worldwide. He holds two patents for technology innovations in human factors.

Thursday, May 12, 2022 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

Many organizations have yet to figure out how to fit digital, hybrid, and decentralized clinical trial methods into their existing ecosystems in a scalable and efficient way. This webinar will go through the complexities that decentralized and hybrid methodologies bring to first-generation platforms, and how a single, unified platform enables interoperability and flexibility to help truly unlock the potential of these digital study methods.

Accelerate critical insights from all digital, hybrid, and decentralized clinical trial data

With the increasing volumes of adverse event reports and stagnant budgets, the time is now for a revolutionary change in drug and device safety case management. A robust management process is necessary for identifying and evaluating adverse events (AE) and reporting them properly to regulators.

The Next Domino: Automation, AI, and touchless safety case processing

What if you could predict potential safety issues before clinical development begins? Innovative new signal detection and management approaches have been developed to help clinical trial sponsors, manufacturers, and CROs combat safety-related challenges and provide insight to be used to predict potential safety issues even before clinical development begins. Applying those learnings to their choice of initial research candidates can ultimately mean safer medicines for patients.