ACDM Awards 2023 Results

The ACDM Annual Awards allow our Members and Non-members to showcase their achievements in the management of clinical data. There are three Awards to be awarded each year. 2023 Winners will be announced at ACDM23 on the 13th March in Barcelona.

The Award categories are:

Individual Excellence in the Management of Clinical Data Award

Team Excellence in the Management of Clinical Data Award

Innovation in the Management of Clinical Data Award

Individual Excellence in the Management of Clinical Data Award

WINNER

Emma Wrixon
Emma Wrixon truly deserves recognition for her work as a data manager and adopting an innovative, technological forward attitude towards data management, especially pertaining to the decentralized trial space. When the pandemic hit and COVID was at the forefront of clinical trials, Emma arose to the occasion with determination, and utilizing her knowledge of data management, set up a truly decentralized trial, that met recruitment and delivered clean, reliable data. Not only did Emma play a role in planning and setting up the data management aspect of the DCT, she also was responsible for programming the study design in the EDC including all eCRFs, edit checks, custom functions and alerts, along with design and programming of the ePRO. The study also involved integrating EHR data directly into the EDC which Emma helped to program and establish. Leading the initiative to set up a DCT is a hard stressful task, adding in the additional tasks of system programming shows that Emma has strong leadership, strong critical thinking and can tackle any challenge.

RUNNER UP

Priya Deshpande
Joining GSK in March 2021 as Senior Manager of the coding team with absolutely no relevant background or expertise, Priyanka not only established a coding team in Bangalore, India from the scratch but also aced at every step. Managing 12+ experienced coders, taking knowledge transfer, revamping entire process to be at par rather exceed current Industry standards, implementation of new ideas for process improvement and most importantly create an environment where team is more inclined towards innovation and development. Work Priyanka did in last 1.5 years is worth at least a decade and definitely boosted GSK’s performance greatly. One of the most admired and trusted person in the organization, she deserves all the accolades.

RUNNER UP

Hannah Gills
Hannah Gillis has transformed the Data Management service to offer a wider breadth of clinical trials and increased excellence in service provision. Hannah’s leadership of the data management team is invaluable and a significant contribution to the growing profile and success of MAC Clinical Research. Hannah’s continued example as a leader and an experienced Data Manager has inspired a growing team to develop a larger, more diverse, more capable, and more experienced Data Management team. Hannah’s demonstrated an invaluable impact on the Data Management service and MAC Clinical Research as a whole.

Team Excellence in the Management of Clinical Data Award

WINNER

Cancer Research
In November 2022, Cancer Research UK’s Centre for Drug Development (CDD) opened the DETERMINE trial, an umbrella-basket platform trial to evaluate the efficacy of licensed targeted therapies in rare adult, paediatric and teenage/young adult cancers. In DETERMINE, each treatment option is a basket or treatment arm, and each of these has its own detailed appendix to the protocol. As the plan for the trial is to have up to 20 arms, opening when new partners join the collaboration, and with each treatment arm expanding and closing as data are available, the CDD Data Management Team decided to build a clinical database in Medidata Solutions Rave for each treatment arm. Resourcing the five database builds was difficult, the CDD Data Management Team is small, comprising of only two Clinical Database Programmers, and at that point, three Clinical Data Managers (CDM), two of which had no available resource due to commitments on other trials. When the DETERMINE protocol was approaching finalisation, the team kicked off the development of the database for Treatment Arm 1, having decided to develop one database through to ready to go live and then using this database as the standard, where possible, for all other arms as there were a lot of non-CDD standard eCRFs required with input needed from many stakeholders. Due to amendments to the protocol requested by regulators, the specifications for all treatment arms changed during their development, increasing the complexity of the process and the resource required. The average time taken to develop a database in the CDD is 18 weeks, the Data Management Team delivered all five databases in time for trial open, and in 34 weeks from the initial kick off whilst continuing to meet all deliverables on other trials.

RUNNER UP

eDigital Team
For the creation of the DCT white paper titled: Embarking on a DCT journey – A data manager’s guide, available on the eDigital team webpage through the ACDM. This project was led by Richard Moore and authors included Jenna McDonnell, Natalia Sofia, Tracie Lavery, Ioulietta Mulligan. Reviewers include Doug Bain, Vishal Kapoor, Marcus Schwabedissen, and Santosh Karthikeyan Viswanathan, Ph.D. The document will have a wide impact for the entire ACDM community, enabling members to consider a range of factors when implementing DCTs and helps to position data managers as key stakeholders in the decision making process.

RUNNER UP

Pivotal
The Biometrics team at Pivotal is a relatively small global team of about 20 expert individuals made up of data managers, statisticians, clinical programmers, data coordinators and CDISC programmers many of whom have worked together more for 20 years now. The Pivotal Biometrics team is a community in the true meaning of the word, a group of people who work together and consciously continue to grow and develop together. This year, the team took the initiative to bring together the knowledge and benefit of their experience they have gathered over the years working on oncology studies, to help support future sponsor clients by reducing implementation times significantly as well as making this a more cost-efficient process.

The Biometrics team worked closely together during 2022 to develop a platform agnostic, semi-automated standardised approach to produce oncology focussed electronic CRFs, bringing implementation time from the industry standard for oncology studies of 12-16 weeks from final protocol to as low as 4 weeks as well as reducing biostatistics & programming effort required for TLF production.

The oncology focussed clinical trials are often considered the most complex to support within the drug development industry, due to their intricate CRF designs with potentially multiple phases, cohorts and treatment arms. Due to the team’s extensive historic experience of this, the Pivotal team are now able to offer the benefit of their wealth of experience in this space to prospective sponsor clients simplifying this process dramatically and consequently reducing cost and timelines for sponsors substantially.

Innovation in the Management of Clinical Data Award

WINNER

Pfizer DM
Ashley and the team have implemented innovative software for management of clinical data in multiple high profile Clinical Programs. Pfizer led the drive for a Covid-19 vaccine in collaboration with BioNTech, with their expertise and approaches bringing the vaccine to market in record time.

Ashley and his team introduced Machine Learning approaches to reduce review cycles and time to study closure, bringing in novel software developed though a transformational hackathon, teamed with Pfizer’s clinical know how and process guardrails.

This revolutionary approach led to the database being locked within a day of the last patient visit, bringing the Covid-19 vaccine to market quickly, but have also expanded to support and oncology approval, and moved beyond data cleaning into identifying protocol deviations and specifying medical coding.

RUNNER UP

Saama
The average clinical study accumulates millions of data points and requires more than 400 edit checks. Data managers using manual or semi-automated environments have to wait weeks for updates and waste valuable time reviewing queries that don’t change the data. Saama has accelerated these tedious processes with its smart application, Smart Data Quality (SDQ), to transform clinical drug development through the power of artificial intelligence (AI). Saama’s innovation allows biopharma companies to speed up their clinical trials and bring critical new therapies to market faster for patients that need them. Leveraging AI often takes years of planning, model training, and feedback to achieve positive business outcomes. Saama turned SDQ from pipe dream to reality through hackathons, popular coding events on college campuses with eminent computer science and engineering programs. Hackathons are proving their worth in the corporate world and enabled Saama to aggregate a sufficient volume of quality data to properly train AI models with daily collaboration between biopharma data scientists and Saama engineers. With SDQ, Saama clients find improvement in three important metrics: High-volume reconciliation, unstructured text analysis, and a 15x time savings.

RUNNER UP

Chiesi
The Chiesi team, in collaboration with a provider (ARTIQ), developed an innovative approach based on AI for clinical data quality control. Artificial Intelligence (AI) is a key enabler for Pharma 4.0 and has the potentiality to transform R&D processes delivering significant time and cost efficiencies while providing better faster insights for decision making. In particular, the Chiesi project explored the usage of an AI algorithm for Quality Control of spirometry data compared to the expert technician quality process (overreading) and implemented the digital solution within 2 pilot Clinical Trials. The application of this digital solution allows to improve data quality, speed up current process (manual QC) and reduce patient burden.

Individual Excellence in the Management of Clinical Data Award

This Award will be given to an individual who, in the opinion of the judges, has made a significant contribution to one of the following aspects of the management of clinical data:

Project Delivery
Process Improvement
Quality Improvement

Team Excellence in the Management of Clinical Data Award

This Award will be given to a Team who, in the opinion of the judges, has made a significant contribution to one or more of the following aspects of the management of clinical data:

Project Delivery
Process Improvement
Quality Improvement

Innovation in the Management of Clinical Data Award

This Award will be given to an individual or a Team who, in the opinion of the judges, has achieved one or more of the following:

Implementation of innovation (e.g. clinical trial using new data management tools)
Development and implementation of a new innovative process(es)
Design of physical or virtual solution for managing or collecting clinical data

Timelines

Nominations are now closed

Awards presented at the ACDM Annual Conference: 12 – 14^th March 2023

Finalists

Individual Excellence in the Management of Clinical Data Award

Nomination Process

There are no restrictions on who can nominate someone for the Individual Awards other than it is not permitted to self-nominate. It is permissible to nominate a Team for which you are a member of. Nominations must be made using the online form which is available by clicking on the button below.