The clinical trial industry's single greatest challenge continues to be timely patient recruitment and retention. One major obstacle is trial drift -- the gradual reduction in study knowledge as a clinical trial ages, resulting largely from inadequate staff training about the protocol and good clinical practices (GCP). The problem is further compounded by high turnover among site staff, with industry data suggesting an average CRA tenure of only 18 months to 2 years -- shorter than many studies.
At the same time, regulatory agencies are increasingly demanding proof that global clinical study staff are appropriately trained and assessed in a standardized manner and, depending on the therapeutic area, that ongoing "recalibrations" in staff education and training are performed during the term of a study in order to minimize trial drift. What's more, there is a growing movement in the industry to require site managers and CRAs to earn GCP certification, further underscoring why effective training is a business imperative.
This presentation focuses on how a well-planned, consistent training program can help sponsors and CROs meet or even exceed enrollment deadlines, and thereby speed drug development.
This audio conference covers:
- Patient recruitment as a distinct discipline, and why all study community members need access to its principles
- Who needs patient recruitment training and when
- Knowledge and skillsets necessary for patient recruitment
- Recruitment training as an effective adjunct to GCP training
- What an effective training and assessment program looks like
- Establishing metrics and benchmarks to evaluate training
- Products and services are available to support training needs
- Case studies of training programs and how they impacted patient recruitment
About the speaker:
Linda Wolf is a key member of BBK Worldwide's strategic services group, developing products to meet the patient recruitment needs of life sciences companies, monitoring market trends, building partnerships, and communicating BBK's innovations for decreasing drug development cycle times. In her seven years in patient recruitment, Linda has co-developed and cultivated such BBK innovations as study relations and Good Recruitment Practice, and most recently served as a key architect of BBK's cultural adaptation services.
An engaging trainer and speaker, Linda also leads workshops at investigator meetings and presents regularly at leading industry conferences, such as DIA, ACRP and the Center for Business Intelligence "Clinical Trials in Ascending Markets" conference. She has also been published in numerous trade publications, including Journal of GXP Compliance, DTC Perspectives, and Good Clinical Practice Journal.
Who should attend?
Directors of Training
Directors of Monitoring
Heads of Research and Development
VPs of Clinical Development
Directors of Clinical Operations
Therapeutic Area Leaders
Study Team Leaders
Site Managers
Study Monitors
This audio conference is rated General Interest.