How do you instill quality and efficiencies into your clinical database from beginning to end? Join this webinar, hosted by PHASTAR and Medrio, for insight into steps you can take early in your trial that will optimize your operations throughout. Learn about implementing efficient processes and establishing the parameters that best equip you to assess the quality of your database. You’ll learn how to roll out a quality plan template at study setup and tailor it to meet the specific needs of your study. You’ll use this plan to identify the risks and processes around the review and cleaning of all data as well as the primary efficacy endpoints based on the protocol, analysis plan and, of course, the safety data. Moreover, you’ll learn how to define and set out the acceptance criteria for each of these items, including how and when the criteria will be assessed.
Speakers Sheelagh Aird, Head of Clinical Data Operations, and Gillian Childs, Principal Data Coordinator, of PHASTAR will explore how the ad-hoc browse data facility, data export options, and associated data management reports available in a cutting-edge electronic data capture solution provide the tools necessary to critically evaluate and assess study progress including data entry, data review, and the query metrics. They’ll show how the use of audit log reports, together with an interrogation of the audit trail, enables researchers to quantify risks and provide a full assessment of the acceptance/rejection criteria. Moreover, they’ll discuss how the ability to monitor these risks from the outset of the study enables researchers to address issues from an early stage by targeting the ‘tricky’ data items – thereby improving efficiency, as well as the quality of the data captured, at the earliest opportunity.
At PHASTAR, the constant strive for efficiencies whilst ensuring the delivery of a quality clinical database is paramount to the data management team. Join this webinar for insight into how you, like PHASTAR, can find success in this endeavor.
Sheelagh Aird, Head Clinical Data Operations, PHASTAR
Sheelagh has over 30 years’ experience in clinical data management. She holds a BSc in Pharmacology and obtained a doctorate in Pharmacokinetics from the University of Bath, UK. Following completion of her academic studies, Sheelagh moved into the pharmaceutical industry, working for large, medium and small CROs, heading up data management and programming groups. Sheelagh established her own bespoke data management CRO which she ran for 16 years, conducting studies for multinational pharma and biotech companies alike. She has been involved in all phases of clinical trials across many therapeutic areas, from the large pharmacogenomic studies to the small cell therapy and ATIMP studies. Sheelagh has lead PHASTAR’s Data Management group since 2016.
Gillian Childs, Principal Data Co-Ordinator, PHASTAR
Gil is an experienced data manager with over 25 years’ experience in the pharmaceutical industry. She gained her BSc in Applied Biology/Pharmacology in 1988 whilst working for GSK as a pharmacologist and latterly as a Senior Clinical Data Scientist. She broadened her knowledge of data cleaning, analysis and reporting of clinical trial data whilst working for two other major pharmaceutical companies. As well as leading projects at PHASTAR, she enjoys the technical side of data management including database administration and is skilled in the use of SAS. She is trained in CDASH and CDISC standards and has wide experience of Electronic Data Capture (EDC) software.
Who Should Attend?
Senior clinical data management and clinical operations professionals, including project leads from pharmaceutical, biotechnology, medical device, and diagnostics companies.
What You Will Learn
- Steps you can take early in your trial that will optimize your operations throughout
- How to roll out a quality plan template at study setup and tailor it to meet the specific needs of your study
- How the use of audit log reports, together with an interrogation of the audit trail, enables researchers to quantify risks
Our experienced team of Data Managers are on-hand to advise and support all aspects of data capture and analysis from CRF design through to database lock. We have extensive experience in all phases of trials and work closely with both the clinical and reporting teams to ensure the highest quality data. We are part of Medrio’s Partner Program (Medrio is a fully functional yet affordable electronic data capture system) and can offer cost-effective solutions to suit all needs.
Medrio is a leading healthcare technology company providing eClinical solutions including EDC, eSource, and ePRO for clinical research. Founded in 2005, the company’s cloud-based software platform and mobile suite of products deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient reported outcome responses. Study sponsors and contract research organizations have used Medrio extensively across drug, device, diagnostic, and animal health trials. Medrio has extensive experience in all study phases and leads the market in early-phase trials. The company serves over 500 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. For more information, please visit www.medrio.com.