Automating Phase One Clinical Trials


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Automating Phase One Clinical Trials

  1. 1. Automating Phase One Trials November 5, 2012 Param Singh Vice President, Clinical Trial Management Solutions BioPharm Systems, Inc. Ed Dougherty Senior Sales Consultant Oracle Health Sciences GBU 1 PREVIOUS PREVIOUS NEXT NEXT
  2. 2. Welcome & IntroductionsParam SinghVice President of Clinical Trial Management SolutionsBioPharm Systems, Inc.• CTMS practice director since 2007 – Expertise in managing all phases and styles of clinical trials – Leads the team that implements, supports, and enhances Oracle’s LabPas and Siebel Clinical solutions• Extensive Siebel Clinical implementation experience – 11+ years of experience implementing Siebel Clinical – 15+ implementations – Spearheaded the creation of the Siebel Clinical “accelerator” ASCEND 2 PREVIOUS PREVIOUS NEXT NEXT
  3. 3. Welcome & Introductions (cont.)Ed DoughertySenior Sales ConsultantOracle Health Sciences Global Business Unit• 17+ years of experience in Life Sciences – Primary focus: clinical development – Facilitates client understanding of Oracle Health Sciences applications through presentations, demonstrations, and workshops – Prior to joining Oracle, worked for Medidata, leading implementations of their EDC solution and helping to define their product strategy 3 PREVIOUS PREVIOUS NEXT NEXT
  4. 4. Agenda• Historical approach to managing phase I trials• Challenges of historical approach• Emerging trend toward automation• Overview of LabPas, Oracle’s phase I clinic automation solution• Minimum requirements for phase I solution• Time for questions 4 PREVIOUS PREVIOUS NEXT NEXT
  5. 5. Current State of Phase ISince 2008, phase I costs have increased:• 32% for subject recruitment• 68% for each subject per trial• 108% for staffingThe biggest challenge, according to sponsors, is finding “trialsites and clinical research organizations that can yieldreliable, high quality data.” -- Clinical Trial Costs Are Rising Rapidly Pharmalot,, 26 July 2011 5 PREVIOUS PREVIOUS NEXT NEXT
  6. 6. Phase I Trial Management, HistoricallyAlmost entirely paper-based 1. Volunteer recruiters manually verify study eligibility 2. Nurse/Technician records screening and study data by hand on paper 3. Human “checkers” stand behind Nurse/Technician and verify data is recorded accurately 4. Data entry personnel manually transcribe data from paper to database 5. Monitor compares database to paper records 6. Data entry personnel investigate and correct errors/discrepancies 7. PI reviews data 8. Reports are manually generated for each sponsor 6 PREVIOUS PREVIOUS NEXT NEXT
  7. 7. Challenges of Historical Approach• Recruiting volunteers – Failure to recruit full subject groups can delay a trial and increase costs• Complex workflow – Data is collected at a rapid pace and in a highly structured manner, and trial design often changes• Scheduling studies – Lack of visibility into the availability of beds and staff to conduct each trial makes it difficult to bid correctly and maximize revenue 7 PREVIOUS PREVIOUS NEXT NEXT
  8. 8. Challenges of Historical Approach (cont.)• Sample integrity – Need to collect samples on time, track their location, and store them properly to preserve data integrity• Evidence of processes – SOPs show planned processes; need contemporaneous data to provide evidence• Accurate data capture – Missing or erroneous data can invalidate results and necessitate a partial or complete repetition 8 PREVIOUS PREVIOUS NEXT NEXT
  9. 9. Emerging Trend Toward Automation“Historically, these challenges have been addressed withincreasingly intricate paper processes. These studies are,however, becoming more complex. The unit mustaccommodate the requirement that early phase trials delivera first look at efficacy and stakeholders desire to share datarapidly. Meanwhile, the units aim to take on larger numbers ofstudies. All of these factors are leading to the simpleconclusion that paper processes are no longer practical.” -- Automating Phase I Trials, Applied Clinical Trials, 1 August 2010 9 PREVIOUS PREVIOUS NEXT NEXT
  10. 10. Oracle Health Sciences LabPas• Flexibility – Early phase study protocols can change quickly – Last-minute setup, schedule, and barcode label changes easy to manage (even after study has begun)• Configurability – Define all the major elements of a study • Sample processing requirements, configuring edit checks, etc. – Expansive reporting and data export structure• Control – Designed to reduce errors and queries • Direct data capture • Sample processing automation • Real-time edit checks and alerts 10 PREVIOUS PREVIOUS NEXT NEXT
  11. 11. Key Benefits of LabPas• Subject Recruitment – Study volunteers recruited quickly with an easy-to-use customizable, scripted data collection wizard and appointment scheduling tools – Volunteers automatically evaluated based on configurable inclusion and exclusion rules• Direct Data Capture – Automation dramatically reduces the need for paper from clinical trials – Real-time study data collected and checked when the technician is with the subject; no delay in data entry or verification 11 PREVIOUS PREVIOUS NEXT NEXT
  12. 12. Key Benefits of LabPas (cont.)• Sample Management – Barcode-driven sample management efficiently captures data and controls sample process – Customizable edit checks and alerts reduce input and sample processing errors• Data Management – Data visualization, data review/approval, metrics and query management allow effective qualification of electronic source – Key decisions made earlier when real-time data is available to both investigators and sponsors• Reporting – Data can be evaluated and easily transferred to the sponsor with flexible reporting capabilities 12 PREVIOUS PREVIOUS NEXT NEXT
  13. 13. Features & Functions of LabPas• Volunteer lookup based on demographics and clinical history• Volunteer screening, appointment scheduling, and screening data entry• Flexible study and data capture setup enables rapid configuration of study protocols• Barcodes labels (subjects, dosing, tubes, instruments) improve workflow 13 PREVIOUS PREVIOUS NEXT NEXT
  14. 14. Features & Functions of LabPas (cont.)• Define multiple clinics to enable global early phase deployment strategies• Configurable security roles, electronic signatures, and a complete audit trail• Sample storage management and temperature monitoring 14 PREVIOUS PREVIOUS NEXT NEXT
  15. 15. Anticipated Phase I Trend• Phase I clinics will continue to automate their operations to differentiate themselves – More competitive bids – Higher quality data – Faster data sharing• Sponsors will continue to seek out phase I clinics that have automated processes – Time and cost savings – Increased compliance – Greater confidence in data, leading to better go/no-go decisions 15 PREVIOUS PREVIOUS NEXT NEXT
  16. 16. Recommendations for a Phase I Solution• Minimum requirements should include: – Robust volunteer database – Call center scripts / decision trees – Automatic verification of study eligibility – Staff scheduling functionality – Screening event tracking – Electronic data capture on the clinic floor – Automatic edit checks – Sample tracking – Portal for sponsors to review data – Trusted/reliable software vendor 16 PREVIOUS PREVIOUS NEXT NEXT
  17. 17. Thank you for attending!Questions? 17 PREVIOUS PREVIOUS NEXT NEXT
  18. 18. Contact Us• North America Sales Contact: – Rod Roderick – – +1 877 654 0033• Europe/Middle East/Africa Sales Contact: – Rudolf Coetzee – – +44 (0) 1865 910200• General Inquiries: – 18 PREVIOUS PREVIOUS NEXT NEXT
  19. 19. Presenter – Param Singh• Contact – – +1 210 454 5192Param has been working in the life sciences industry hisentire career. As vice president of CTMS at BioPharm, hedeveloped the CTMS practice to become one of the best inthe industry.With a knack for resource and project management, Paramleads a highly skilled team of implementation specialists andcontinues to build lasting relationships with clients. 19 PREVIOUS PREVIOUS NEXT NEXT
  20. 20. Presenter – Ed Dougherty• Contact – – +1 610 579 3705Ed has over 17 years of experience in the life sciencesindustry, primarily focused on the clinical development space.For the past four years, he has been part of the Oracle HealthSciences Global Business Unit, supporting various clinicalsolutions, such as LabPas.Ed facilitates client discussions surrounding the benefits ofOracle Health Sciences applications through detailedpresentations and workshops. 20 PREVIOUS PREVIOUS NEXT NEXT