ACDM Awards 2022
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.
2022 Winners will be announced at ACDM22 on the 14th March in Edinburgh.
Individual Excellence in the Management of Clinical Data Award 2022: Winner
Gil is everything that today’s data manager should be. Not only is she an outstanding role model by encouraging critical thinking skills in her team and contemporaries, she is focused, dedicated and a fantastic ambassador for Data Management. She approaches every task with drive, complete understanding and is able to interpret the big picture and influence others while producing work to the highest quality – best clinical practices are demonstrated every day, in everything she does.
The particular outstanding contribution I want to nominate Gil for, is her work as a data management consultant, working within our sponsor’s teams as a member of their in-house resource. She has performed this role in different circumstances and for different companies. Currently she is in a small team of Data Managers which stepped in to support a customer during some changes in their in-house team. Gil has led this team through a number of locks, preparation for a mock inspection and subsequent planning towards a regulatory inspection. She successfully managed a particularly difficult lock, and has been designated as the Data Management Subject Matter Expert for the inspection, a very difficult task given the short amount of time she and the team have had to get to grips with the whole history of the program under inspection. The feedback she received as a result of her tireless dedication to uncovering the story of each project, working with different vendors and the other internal team members has been fantastic, the customer couldn’t have enough good things to say about her relentless quest for organisation and her dedication to piecing everything together to the point that they entered the mock inspection with utter confidence in her ability to represent data management to its best.
Individual Excellence in the Management of Clinical Data Award 2022: Runner Up
Nach heads the Clinical Programming, Data Analytics and Reporting in Late Phase Data Management. She is a lead by example as her efforts are valued within the organization in terms of thought leadership, driving Innovation, effective stakeholder management and thinking out of box to bring in efficiency in Clinical Data Management activities. She has a blend of both Clinical domain and technical expertise which makes her unique to manage the portfolios & people in her remit. She has exhibited strong leadership skills during ambiguous situations in project delivery and highly valued in the team for her contributions and efforts. It is commendable to have such women leadership with strong collaborative skills in the organization to build strong clinical programming teams delivering value across the Therapeutic areas.
Team Excellence in the Management of Clinical Data Award 2022: Winner
PPD COVID Team
PPD supported a big variety of COVID vaccine studies across many clients and would like to nominate two of them which commenced in Jul 2020 during the early stages of the pandemic. These were pivotal for the client to demonstrate efficacy of their protein-based Covid-19 vaccine. PPD teams were tasked with rapid, unprecedented timelines to not only commence the studies, but to enrol (20,000 subjects in total across both studies within 2 months), accrue the required endpoints, clean the data and provide efficacy outputs for efficacy readouts and emergency use authorization submissions within just over 3 weeks in UK for example whilst ensuring quality is maintained throughout. Quality was proven by an MHRA inspection with zero critical findings for the UK study. The competitive Covid-19 Vaccine development landscape in the United Kingdom and South Africa as well as the United Kingdom Government Vaccine roll out has driven the necessity for tight start up timelines with a narrow window for enrolment and need for analysis and reporting of results at lightning speed.
Team Excellence in the Management of Clinical Data Award 2022: Runner Up
The team of Clinifidence has been involved with one of Danone Nutricia Research’s clinical studies and they have showed an enormous amount of dedication to the trial. Not only are they spot on time for all their deliverables, they also actively think with the client (us) on how to improve aspects of the study. For example, they proposed a mid study change to make the work more efficient. Not every CRO would do this. Furthermore, they are a very nice team to work with and go out of their way to support the client. In the last years they have grown as a company, showing that we are not the only clients who like their work.
Innovation in the Management of Clinical Data Award 2022: Winner
IQVIA Data Management
In 2018, presented with the challenges of ever-increasing data volumes and industry pressures to deliver faster while maintaining high quality and without increasing cost, IQVIA Global Data Management realized traditional, manual and batch cleaning operational models would not be adequate to address the market needs. We conceptualized Real-Time Data Cleaning (RTDC), a strategy which leverages centralized clinical data in a data lake, standards managed in metadata repositories, and workflow technology to enable automation of our data flows and review processes which began construction of our solution.
In 2020, we completed the initial design and released the process for use on new studies. The tech-enabled processes and automation were enhanced during this time leading to all new studies using RTDC as the delivery model by 2021. The team continued refinement of the technology and processes in 2021 and now have 100+ studies running RTDC, 6 of which have completed Database Lock.
Innovation in the Management of Clinical Data Award 2022: Runner Up
Arun has been the driver behind many areas of innovation both at Novartis and at AstraZeneca. He has led the development of tools that machine read a protocol and data mines similar protocols to return the standards that should be considered for the reference study. Arun has also led the development for edit check optimisation, and a risk dashboard. Arun has a thorough understanding of data management and is constantly looking for ways to reduce cycle times and improve quality. Arun has helped create the job description for a data curator role at AZ and provided use cases for them to work on
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