Execution in Clinical Research

Transcription

1 TM TM Execution in Clinical Research Unrivaled CRA training program drives success for Sponsors. Sponsors have many choices in choosing development partners at the CRO level. The need for a documented and effective training and development program in place at the CRO level ultimately plays a major part in project success. There is an industry need for CRA training. After all, a CRA serves as the main investigative site staff contact and liaison for the Sponsor during the trial. Medpace has a proven track record of conducting successful clinical trials, with a credited 30 approvable NDA submissions. Many of our monitored sites have undergone successful global regulatory audits over the years. Furthermore, Medpace has been called upon for rescue monitoring on several occasions. One reason for our success starts with our employees. The level of commitment and dedication to quality allows us to offer exceptional service. At Medpace, we invest in the development of our employees from the very beginning. In fact, Medpace scores above all named competitors for CRA Quality 1 in the recent ISR CRO Quality Benchmarking report, Phase II/III. Medpace maintains an independent, global training and development department for Clinical Research Associates within Clinical Operations. The Medpace Global Clinical Monitoring group consists of CRA Managers/ Line Managers, with responsibilitiy for initial and ongoing training of each CRA, as well as onsite evaluation visits and quality of CRAs globally essential to ensure consistent compliance with SOPs and ICH-GCP. Most clinical trial practitioners will agree that the level of CRA training is a deciding factor when awarding a new trial. Medpace believes the global curriculum created for our CRAs should serve as an industry standard. All Medpace CRAs, regardless of background, undergo continuous instruction utilizing various types of training and educational forums. CRA Training Best Practices Best practices in trial management include the following criteria with regard to the training of clinical trial professionals in managing large global projects.

2 Page 2 of 6 Training criteria and focus CORE MEDPACE SOPs FORMALIZED MENTORING OBSERVATIONAL TRAINING ON-SITE MONITORING MEDPACE CRAs PROJECT SPECIFIC TRAINING CLINICAL MONITORING OVERSIGHT SUPPORTED SUCCESS Industry Recognition for Medpace Quality in Clinical Operations Teams Lower CRA turnover Synchronized project teams

3 Page 3 of 6 Core SOP review and other training sessions CRAs begin training by completing a thorough review of SOPs relevant to their position. This review takes place within a classroom and/or via a web-based setting overseen by Clinical Monitoring Associate and specialty departments within Medpace. New CRAs attend over 35 training sessions. During these sessions, the CRA will review SOPs from Clinical Operations, Clinical Safety, Regulatory Submissions, Quality Assurance, and Data Management. This formal inter-departmental training ensures a full understanding of project workflows, and how the CRA can affect quality and timelines at each stage of the trial process. Extensive training is also presented on the ClinTrak Study Management and Data Management systems, along with training in ICH/Good Clinical Practices, FDA Code of Federal Regulations, EU Directives, as well as any local regulations pertinent to that CRA s region. Both pharmaceutical and medical device regulations are reviewed extensively. New CRAs study current relevant Regulatory Authority documentation and guidance documents, as well as participation in report writing, targeted workshops and other hands-on exercises. Workshop and exercise topics include source documentation, investigational product accountability, data query management, etc. Once the SOP sessions, ancillary trainings, and software reviews have been completed, the CRA is tested to demonstrate knowledge of all monitoring-related procedures. A score of 80% or greater must be achieved on the electronic Medpace SOP exam. CRAs also attend ICH/Good Clinical Practice (GCP) overview sessions as well as participation in a training dedicated solely to industry guidance documents and information sheets. Formal CRA Mentoring Programs in place One of the best features of Medpace CRA training is the mentoring program. Each new CRA is assigned a mentor, who is a more experienced CRA. The role of the mentor is to act as a coach, providing guidance and support throughout the new CRA s training. With the mentor s oversight, the new CRA participates in a series of role playing activities, which are structured to provide exposure to real world situations. The CRA performs complete qualification, study initiation, routine and closeout visits. These mock exercises are focused and quite detailed; with most requiring comprehensive presentations. Monitoring of the Investigator Site File (ISF), patient source worksheets, patient medical records, CRFs/eCRFs, and investigational product accountability/return is also included. After each mock exercise, the new CRA receives comments and feedback, both written and oral. Every effort is made to ensure this feedback is meaningful to the new CRA, which allows him/her to apply it in a way that facilitates their growth and development.

4 Page 4 of 6 Participation in on-site monitoring New CRA trainee s participation in on-site monitoring visits allows them to begin to apply the classroom knowledge, exercises and testing at the site level. At least 4-6 on-site training visits are expected. These visits encompass a number of protocols (generally 2-3). This allows the new CRA to understand the interworking of different protocols as well as different Sponsors. The first two visits are observational; the new CRA travels to the site with the trainer and works closely with him/her. As the visits progress, the new CRA is asked to assume a more active role, taking on additional responsibilities and tasks. After reviewing all work, the trainer evaluates the new CRA, providing verbal and written feedback in a standardized forum. These evaluations permit the Clinical Monitoring team to establish expectations for subsequent visits while also providing a clear picture for additional training that may be warranted. The trainer gains valuable feedback, as he/she is evaluated by the new CRA in a standardized forum as well. The entire CRA orientation process is expected to be completed in 3-6 months. During this period, the CRA is dedicated solely to training in the CRA position. Once Clinical Monitoring determines the new CRA is ready, they will begin working on clinical trials. Project-specific training Once the new CRA is assigned to a clinical trial, the Clinical Trial Manager is responsible for ensuring all members of the project team undergo project-specific training. Initially, this is done during a Protocol Review meeting and/or Monitoring Plan meeting. Topics covered in this training include protocol review, CRF review, review of safety reporting, etc. Therapeutic training is typically facilitated by the Medical Monitor. Clinical Monitoring Oversight Although the initial training program is now finished, training itself is far from over. The Clinical Monitoring team provides ongoing training, which is face-to-face and internet/module based. Over 30 monitoring-related electronic training modules (which include both voice and slide presentations) with corresponding electronic testings are offered. Such ancillary training performed in the past includes SAE training, training in particular therapeutic areas, training in site relations, etc. In addition to continually offered training sessions, the CRA Manager/Line Manager within Clinical Monitoring performs home-office and on-site evaluation visits, review of monthly quality metric reports, and site clinical research coordinator telephone surveys to assess CRA performance. CRA Managers remain in close contact with each CRA, ensuring the CRA is supported in all facets. There is also a communication bridge in place between CRA Managers/Line Managers and Clinical Trial Managers, so the CRA receives well-rounded feedback, guidance and development. Medpace Clinical Monitoring is constantly striving to improve and welcomes comments and suggestions. All CRAs are encouraged to provide feedback regarding their training experiences. Allowing them to contribute and freely share ideas fostering motivation and productivity. They know they are valued and respected. This, in turn, fuels self-confidence, morale, and commitment. It s no secret our monitoring turnover rate is around 5% - less than half that of the competition!

5 Page 5 of 6 Award Winning Strategic Relationships Medpace CRA Training supports Medpace success in the industry. Medpace has historically been noted as a quality provider in the CRO Industry. Recently, Medpace scored highly in the 2014 Industry Standard Research, CRO Quality Benchmarking survey - placing highly among top competitors and led the group in key attributes including CRA Quality, Responsiveness, and Staff Turnover in recent Industry Standard Research, CRO Quality Benchmarking, Phase II/III Service Providers, ATTRIBUTE CRA Quality Responsiveness Innovative Solutions Staff Turnover Project Mgr. Quality Project Team Chemistry Therapeutic Expertise Data Quality Database Lock Timelines Meeting FPFV Timelines Network of Investigator Sites Patient Recruitment Strategies LED THE GROUP SCORED HIGHLY Source: CRO Quality Benchmarking, Phase II/III Service Providers, Industry Standard Research, March 2014.

6 Page 6 of 6 Investigator and Site relationships consistently prefer Medpace CRAs Other industry awards include a two year Eagle Award from Site Solutions, noting investigator preference for Medpace as a preferred CRO. Clinical research sites honor Medpace as Top CRO at Site Solutions Summit 3,4 Nearly 400 sites voted via confidential ballots to select the 2011 and 2012 Site Solutions Summit Eagle Awards recipients, evaluating companies they had worked with in the last 18 months on criteria that included professionalism, partnership, efficiencies and financial considerations. The sites votes represented their collective voice in naming Medpace as the most desirable to work with as a clinical research study partner. Medpace receives top scores for speed of site and investigator recruitment and for upfront contingency planning, in the 2013 CRO Quality Benchmark Report 5 In 2013, Industry Standard Research reported that mid-sized ISR CROs like Medpace performed quite well or even better than their larger counterparts and they received higher marks for service quality and loyalty overall. The CRO Quality Benchmarking Report - the results of an annual survey of pharmaceutical company executives and professionals from around the world - reveals that Medpace scored highest in two key categories: recruitment and contingency planning. 5 Sources: 1,2 CRO Quality Benchmarking, Phase II/III Service Providers, Industry Standard Research, March , Site Solutions Conference, Eagle Awards CenterWatch, Clinical research sites honor Eli Lilly Medpace with Eagle Awards, Centerwatch.com, 15 October 2012, web. CenterWatch, Eagle Awards Honor GSK, Medpace, Quorum - IRB, Centerwatch.com, 21 October 2011, web. 5 CRO Quality Benchmarking, Phase II/III Service Providers, Industry Standard Research, 2011