Catherine Celingant

The Content Alignment Committee is composed of two members from each of the GCDMP©, Certification, and Education Committees and members of the Board. The committee is responsible for increasing alignment between these three key SCDM offerings.

SCDM and Clinical Drug Development in the time of COVID19 - Rapidly Evolving CDM To Meet A Changing Healthcare and Clinical Trial Landscape

The global COVID19 Pandemic has impacted not only drug development and clinical trial conduct worldwide, but the entire healthcare paradigm. Within months of the initial spread of COVID19, clinical trials sites globally were shut down, patient access to sites as well as staff access to sites was severely limited, and as a result so was data creation, data collection and source document verification. Telehealth visits, as well as remote patient monitoring went from a rarity to a standard of care – in some cases Telehealth use increased up to 5000% beyond pre-COVID19 levels. Clinical Data Management methodologies had to rapidly evolve to ensure data and trial integrity using both existing and novel technologies to solve for Remote Patient Monitoring, Remote Data Capture and Remote Data Monitoring. CDM technologies such as IoMT and EHR integration, the use of AI and ML all will be essential to a Post COVID19 trial paradigm. To solve the COVID19 global pandemic will require hundreds of thousands of patients in vaccine trials – collecting and analyzing data at unprecedented volumes and speed. CDM and novel CDM strategies to solve for these issues will be one of the most critical success factors to ensuring we keep clinical trials active during COVID19 and that we find a vaccine for COVID19.

CDM in 2030 – What the future holds?

While it would be presumptuous to attempt to predict what 2030 is about, there are clear signals that it would be vastly different than today. The changes in clinical research approaches, the rapid advances in technologies and the generalization of risk-based approaches endorsed by regulators have all started to reshape our discipline. Some organizations have already successfully embarked into the Artificial Intelligence journey and expect to release data review tools powered by Machine Learning in 2021 (i.e., TOMORROW!). If it was not enough, COVID-19 has added fuel to the fire by accelerating the decentralization of clinical trials. This trend is global and EMEA cannot dodge the bullet. There is no going back, we have past the inflection point leading us toward an exciting but different future. Join the SCDM Innovation Committee Chair if you want to better understand what is looming in front of us.

Risk-based Quality management in CDM

This topic will focus on Risk Based Management from a variety of angles including the quality of the data produced.

Submissions should focus on matters related to risk-based approaches and how they impact CDM:

– RBM’s impact on CDM and visa versa

– Risk-based CDM approach

– QMP management

– QMP with source diversification

Collaboration Internal Teams and Customer Focus

This topic should cover the methods of handling the collaboration between customer and clinical data management (i.e. CDM and clinical trial teams, CDM and sites, CMD and CRAs, CDM and subjects, etc.).

Risk-Based Quality Management

This topic will focus on Risk Based Management from a variety of angles including the quality of the data produced.

The Fine Art of Clinical Data Management

This topic should cover how CDM organization behaves with respect to the CDM community, what are the potential improvements we should work on in the future, what are the lessons learned from past experiences, etc.

Innovation

This topic should cover real approaches on new technological and innovation approaches not covered in previous topic and/ or coming not necessarily from CDM (e.g. public health management, finance, physics, etc).

The Future of CDM

This topic should focus on real cases showing how academia/ Academic Research Organizations (ARO), CRO and pharma are handling data integrity for eSource, adaptive trial design, how they can assure quality by design, what are their perspectives about actual and potential consequences on CDM, how role & responsibilities are changing and will change in the transformation from CDM to Clinical Data Scientist, what will be the relationship with ‘other’ groups (ClinOps, medics, etc.).

Technology

This topic should cover real procedures on Data Management best practices and metrics for different data sources (wearables, apps, sensors, Big Data), application of ML/AI/Bots/Big Data Challenge in data analysis, Computer System Validation processes for home-grown applications/functionalities, new study designs, use of Real-world data in clinical development.

AGENDA

08:00 AM – 08:10 AM	Introduction to SCDM Mayank Anand Head Global Data Management Service Delivery for Global Clinical Operations, Bristol Myers Squibb (BMS), Member, Board of Trustees SCDM
08:10 AM – 08:20 AM	Introduction to First Virtual Single Day Event Shobhit Shrotriya Life Sciences R&D Operations,Accenture, SCDM India Steering Committee Chairperson
08:20 AM – 09:00 AM	Keynote Speaker 1 Concept of Virtual Trials in the Current Digital Era Craig Lipset Advisor & Founder, Clinical Innovation Partners
09:00 AM – 09:40 AM	Keynote Speaker 2 Virtuals Trials and the Current Covid Situation Kent Thoelke EVP and Chief Scientific Officer, PRA Health Sciences
09:40 AM – 10:20 AM	Keynote Speaker 3 Virtual trials from a Technology Perspective with Case Studies Michael Tucker Senior mHealth Product Specialist, Medidata Solutions
10:20 AM – 10:45 AM	Break
10:45 AM – 11:30 AM	Panel Discussion Reimagining Clinical Research – Enhancing the ‘Patient Centricity’ through Decentralized Clinical Trials
11:30 AM – 12:00 PM	Platinum Sponsor Presentation Oracle Health Sciences
12:00 PM – 01:00 PM	Lunch Break
01:00 PM – 02:30 PM	Industry Workshop 1 Medidata Solutions Virtual Trial Technologies to improve patient enrollment, retention, and engagement
02:30 PM – 03:00 PM	Break
03:00 PM – 04:30 PM	Industry Workshop 2 Veeva Systems Technologies that improve site, Sponsor and CRO execution of studies, and how can they address global challenges, like COVID-19
04:30 PM – 04:45 PM	Vote of Thanks Mayank Anand Head Global Data Management Service Delivery for Global Clinical Operations, Bristol Myers Squibb (BMS), Member, Board of Trustees SCDMShobhit Shrotriya Life Sciences R&D Operations,Accenture, SCDM India Steering Committee Chairperson

Panel Discussion

Facilitator: Shobhit Shrotriya
Vice President, Clinical & Regulatory Services,
Accenture Applied Life Sciences Solutions

Reimagining Clinical Research – Enhancing the ‘Patient Centricity’ through Decentralized Clinical Trials

The world post Covid-19 will be different and continue to evolve in a dynamic fashion. Changes to the way clinical research is conducted today is certainly imminent. As one can imagine, the innovations in clinical research would happen now more than ever. During this panel discussion, we will discuss how decentralized clinical trials (DCTs) offer a more patient-centric approach with fewer visits to the clinic, thereby reducing the burden on investigator, patient and health caregiver. During this changing time, the critical imperatives of DCTs would be to focus on patient safety, ensure data quality and maintain research continuity seamlessly.

Key themes:

Decentralized Clinical Trials – the approach, challenges and proposed risk mitigation strategies
Guidelines for enabling remote patient enrollment, patient screening, consent and data capture processes
Patient engagement through use of technology – ePRO, wearable devices, video calls, etc.
Data Capture and Data Integration from varied data sources – EDC, ePRO, eCOA, Wearables, EMR, EHR, etc.

Executive Director, Data Monitoring and Management, Pfizer

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