Who We Are How We Can Support your Project 2008
ProTrials’ History <ul><li>Founded in  1996  by two CRAs with 18 years of clinical operations experience between them </li...
ProTrials’ Staff <ul><li>Set precedent of hiring experienced staff </li></ul><ul><li>Monitors have an average of  10  year...
ProTrials’ Services <ul><li>We focus on what we know </li></ul><ul><li>Internal – Clinical Operations </li></ul><ul><ul><l...
Our Mission <ul><li>ProTrials is dedicated to providing the clinical research industry worldwide with professional service...
ProTrials Today CONFIDENTIAL  Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
Our Offices <ul><li>Corporate Office </li></ul><ul><li>444 Castro Street, Ste 900 </li></ul><ul><li>Mountain View, CA </li...
Our Organization CONFIDENTIAL  Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
Role Descriptions <ul><li>Project Manager :  Primary contact with client, overall responsibility of ProTrials team managem...
Our Staff <ul><li>75  Full time employees located in the US </li></ul><ul><li>22  Subcontractors located in the US and Can...
Staff Locations - US CONFIDENTIAL  Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09 Strategically loca...
Staff Locations in Other Countries CONFIDENTIAL  Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
Full Service Outsourcing <ul><li>ProTrials has been successful working together with partners to provide a full service op...
Our Key Services <ul><li>Project management  </li></ul><ul><ul><li>Team management </li></ul></ul><ul><ul><li>Vendor manag...
Expanded Services <ul><li>Clinical Operations Specialists </li></ul><ul><ul><li>Project management </li></ul></ul><ul><ul>...
Original Goals Have Been Maintained: <ul><li>Experience </li></ul><ul><ul><li>Staff continues to have a high level of expe...
Our Core Values <ul><li>Excellence  -  We operate with an unmatched level of integrity and maintain the highest level of s...
Our Core Values <ul><li>Promise   -   Our promise to our customers is that we will always do our best. We will work with t...
Community Commitment <ul><li>Certified Women-Owned Business </li></ul><ul><li>Certified Green Business in Santa Clara Coun...
ProTrials’ Experience CONFIDENTIAL  Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
Industry Experience CONFIDENTIAL  Copyright @2001 PROTRIALS Corporation. All Rights Reserved. <ul><ul><li>ProTrials Indust...
Client Experience – Partial List <ul><li>Acambis </li></ul><ul><li>Adiana </li></ul><ul><li>Aradigm </li></ul><ul><li>BAS ...
Therapeutic Experience - ProTrials <ul><li>Total # of Protocols managed to date = </li></ul>CONFIDENTIAL  Copyright @2001 ...
Therapeutic Experience – ProTrials <ul><li>Analgesia </li></ul><ul><li>Cardiovascular </li></ul><ul><li>CNS </li></ul><ul>...
Therapeutic Experience - Staff <ul><li>Cardiovascular – 75% of staff </li></ul><ul><li>Oncology – 75% of staff </li></ul><...
Global and Large Trials- Examples CONFIDENTIAL  Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09 Thera...
How Will We Manage Your Projects? CONFIDENTIAL  Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09 Our S...
Example  Project Team CONFIDENTIAL  Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09 Sponsor (Client) ...
Project Team Communication <ul><li>Effective communication is essential to a successful team </li></ul><ul><ul><li>Agree o...
Project Team Communication <ul><li>Communication Tools: </li></ul><ul><ul><li>Client status reports available at agreed up...
Uniformity Within & Across Studies <ul><li>Focus on retaining team members throughout the life cycle of each study </li></...
Study Management Tools <ul><li>Including: </li></ul><ul><li>Clinical monitoring plan </li></ul><ul><li>Monitoring letter t...
Team Quality <ul><li>Quality CRA performance is ensured by: </li></ul><ul><ul><li>Providing a Monitoring Plan, Visit Repor...
Training <ul><li>In addition to training provided by Sponsors, we provide: </li></ul><ul><ul><li>One-on-one study orientat...
How Can We Grow with Your Project? <ul><li>Global Experience :   International clinical trial management in Asia, Europe, ...
Data Management <ul><li>Alliances: </li></ul><ul><ul><li>Pacific Data Designs (paper & fax) </li></ul></ul><ul><ul><li>Nex...
What Sets Us Apart From The Competition? CONFIDENTIAL  Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
Experience and Retention <ul><li>Our Experience </li></ul><ul><ul><li>Project Managers:  Average of  17  years of industry...
Keys to Successful Teamwork <ul><li>Fully understanding goals and timelines </li></ul><ul><li>Efficient and proactive comm...
Quality Management <ul><li>CRA Quality is Critical </li></ul><ul><li>Oversight of staff by Line Manager & Project Manager ...
Quality Management - Audits <ul><li>We are audited every 1-2 months by prospective and active clients </li></ul><ul><li>Cl...
ProTrials SOPs & Guidelines <ul><li>Audited by a number of clients with no significant findings </li></ul><ul><li>Reviewed...
ProTrials Intranet – Client Access CONFIDENTIAL  Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
Why Choose ProTrials <ul><li>Experience </li></ul><ul><li>High Retention </li></ul><ul><li>Quality  </li></ul><ul><li>Flex...
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Who we are and How can we support your project!

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  • Gen Capabilities Pro Trials Presentation.0808

    1. 1. Who We Are How We Can Support your Project 2008
    2. 2. ProTrials’ History <ul><li>Founded in 1996 by two CRAs with 18 years of clinical operations experience between them </li></ul><ul><li>Both had managed and worked with CROs </li></ul><ul><li>Commitment to provide better service through: </li></ul><ul><ul><li>Clinical Operations Experience </li></ul></ul><ul><ul><li>Flexibility </li></ul></ul><ul><ul><li>Cost effectiveness </li></ul></ul><ul><ul><li>Honest communication with clients and staff </li></ul></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    3. 3. ProTrials’ Staff <ul><li>Set precedent of hiring experienced staff </li></ul><ul><li>Monitors have an average of 10 years of monitoring experience </li></ul><ul><li>Project Managers have an average of 17 years of industry experience </li></ul><ul><li>Employee retention rate over 90% </li></ul><ul><li>Clinical employees average 4 years at ProTrials – several over 10 years </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    4. 4. ProTrials’ Services <ul><li>We focus on what we know </li></ul><ul><li>Internal – Clinical Operations </li></ul><ul><ul><li>Clinical Project Management </li></ul></ul><ul><ul><li>Site Management and Monitoring </li></ul></ul><ul><ul><li>Vendor Management, etc. </li></ul></ul><ul><li>External – Partnerships </li></ul><ul><ul><li>EDC and other vendors </li></ul></ul><ul><ul><li>International clinical operations partners </li></ul></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    5. 5. Our Mission <ul><li>ProTrials is dedicated to providing the clinical research industry worldwide with professional services that demonstrate the highest level of experience, quality, and integrity while assuring career growth and job stability for its employees </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    6. 6. ProTrials Today CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    7. 7. Our Offices <ul><li>Corporate Office </li></ul><ul><li>444 Castro Street, Ste 900 </li></ul><ul><li>Mountain View, CA </li></ul><ul><li>94041 </li></ul><ul><li>Ph: (650) 864-9180 </li></ul><ul><li>Fx: (650) 864-9190 </li></ul><ul><li>East Coast Office </li></ul><ul><li>218 Cassidy Lane </li></ul><ul><li>Chapel Hill, North Carolina </li></ul><ul><li>27516 </li></ul><ul><li>Ph: (919) 960-9370 </li></ul><ul><li>Fx: (919) 967-1324 </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09 www.protrials.com
    8. 8. Our Organization CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    9. 9. Role Descriptions <ul><li>Project Manager : Primary contact with client, overall responsibility of ProTrials team management, tracking timelines, completing client status reports </li></ul><ul><li>Client Manager (Nonbillable) : Global communication with sponsor regarding scope of work, sponsor expectations, project team performance </li></ul><ul><li>Line Manager (Nonbillable) : Primary HR responsibilities for direct reports, conducts annual reviews, assesses training needs, project work load </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    10. 10. Our Staff <ul><li>75 Full time employees located in the US </li></ul><ul><li>22 Subcontractors located in the US and Canada </li></ul><ul><li>200+ Staff available through our Global Partners in: </li></ul><ul><ul><li>Europe (Central and Eastern) </li></ul></ul><ul><ul><li>Latin America (Central and Southern) </li></ul></ul><ul><ul><li>India </li></ul></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    11. 11. Staff Locations - US CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09 Strategically located to optimize cost effectiveness N.Carolina: 14 employees Corporate Headquarters: Mountain View, CA
    12. 12. Staff Locations in Other Countries CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    13. 13. Full Service Outsourcing <ul><li>ProTrials has been successful working together with partners to provide a full service option to our clients </li></ul><ul><li>ProTrials can work with our established partners or can work with partners of your choosing </li></ul><ul><li>ProTrials will ensure: </li></ul><ul><ul><li>Seamless communication </li></ul></ul><ul><ul><li>Efficient project management </li></ul></ul><ul><ul><li>Consistent metric collection </li></ul></ul><ul><ul><li>Aligned goal orientation </li></ul></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    14. 14. Our Key Services <ul><li>Project management </li></ul><ul><ul><li>Team management </li></ul></ul><ul><ul><li>Vendor management </li></ul></ul><ul><ul><li>Recruitment management </li></ul></ul><ul><ul><li>Contract and budget management </li></ul></ul><ul><li>Site monitoring </li></ul><ul><li>Medical monitor support </li></ul><ul><li>Central storage of study documents </li></ul><ul><li>Investigator payments </li></ul><ul><li>Investigator meetings </li></ul><ul><li>Study tool development </li></ul><ul><li>Protocol and CRF development </li></ul><ul><li>Secure client project portal </li></ul><ul><li>Quality assurance auditing </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    15. 15. Expanded Services <ul><li>Clinical Operations Specialists </li></ul><ul><ul><li>Project management </li></ul></ul><ul><ul><li>Site monitoring </li></ul></ul><ul><ul><li>Medical Monitor support </li></ul></ul><ul><ul><li>Recruitment, etc… </li></ul></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09 <ul><li>ProTrials </li></ul><ul><li>Strategic Alliances </li></ul><ul><li>Data Management </li></ul><ul><li>Global Monitoring Partners </li></ul><ul><li>IVRS, Central Lab </li></ul><ul><li>Regulatory, etc… </li></ul>
    16. 16. Original Goals Have Been Maintained: <ul><li>Experience </li></ul><ul><ul><li>Staff continues to have a high level of experience </li></ul></ul><ul><li>Flexibility </li></ul><ul><ul><li>Can provide entire clinical team, or individual staff </li></ul></ul><ul><ul><li>SOPs, forms, and procedures tailored to project </li></ul></ul><ul><li>Cost-effectiveness </li></ul><ul><ul><li>All charges and costs transparent to Client </li></ul></ul><ul><li>Honest communication with Clients and Staff </li></ul><ul><ul><li>Clear communication at all stages of project </li></ul></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    17. 17. Our Core Values <ul><li>Excellence - We operate with an unmatched level of integrity and maintain the highest level of service, while striving to find innovative new ways to help our clients meet and exceed their goals. </li></ul><ul><li>Collaboration - We approach every project ready to work as part of an extended team. Our highly flexible organizational structure and open lines of communication allow us to rapidly adapt to each client’s individual needs, unique requirements, and business processes. </li></ul><ul><li>Integrity - We value the trust our clients put in us and maintain the highest standards so that we can continue to earn that trust. We operate with complete transparency, and implement consistent and highly accountable practices in all aspects of our business. </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    18. 18. Our Core Values <ul><li>Promise - Our promise to our customers is that we will always do our best. We will work with them to overcome obstacles and work diligently toward the success of every project. We are committed to ensuring the success of every project regardless of size or scope. </li></ul><ul><li>Community - We believe that it is our responsibility to help build community leadership and support volunteerism. In an effort to meet this responsibility, we support charitable organizations that positively impact local and global communities. </li></ul><ul><li>Balance - One of the keys to consistently providing our clients with the best possible service is to balance our workload. Before committing to a project, we ensure that we can deliver the resources and support structure required to make the project successful. </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    19. 19. Community Commitment <ul><li>Certified Women-Owned Business </li></ul><ul><li>Certified Green Business in Santa Clara County </li></ul><ul><li>Provide 8 hours annually of paid community service time to employees </li></ul><ul><li>Annual corporate charity contributions based on employee recommendations </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    20. 20. ProTrials’ Experience CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    21. 21. Industry Experience CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. <ul><ul><li>ProTrials Industry Experience: </li></ul></ul><ul><ul><li>Staff Experience in all Phases of Research </li></ul></ul><ul><ul><ul><li>Ph I - 46%, Ph II - 77%, Ph III - 94%, Ph IV - 49% </li></ul></ul></ul>06/07/09 CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved.
    22. 22. Client Experience – Partial List <ul><li>Acambis </li></ul><ul><li>Adiana </li></ul><ul><li>Aradigm </li></ul><ul><li>BAS Medical </li></ul><ul><li>BioMarin </li></ul><ul><li>Chiron (Novartis) </li></ul><ul><li>CV Therapeutics </li></ul><ul><li>Epix Pharmaceuticals </li></ul><ul><li>Fziomed </li></ul><ul><li>Fibrogen </li></ul><ul><li>Genentech </li></ul><ul><li>Guidant (Abbott Vascular) </li></ul><ul><li>Intermune </li></ul><ul><li>Infinity Pharmaceuticals </li></ul><ul><li>Medivation </li></ul><ul><li>NeoRx (Poniard) </li></ul><ul><li>Novacea </li></ul><ul><li>Point Biomedical </li></ul><ul><li>Proteolix </li></ul><ul><li>Roche </li></ul><ul><li>Sinus Pharma </li></ul><ul><li>Spinal Motion </li></ul><ul><li>Tercica </li></ul><ul><li>VaxGen </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    23. 23. Therapeutic Experience - ProTrials <ul><li>Total # of Protocols managed to date = </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09 CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved.
    24. 24. Therapeutic Experience – ProTrials <ul><li>Analgesia </li></ul><ul><li>Cardiovascular </li></ul><ul><li>CNS </li></ul><ul><li>Dermatology </li></ul><ul><li>Endocrinology </li></ul><ul><li>Gastroenterology </li></ul><ul><li>Genitourinary System </li></ul><ul><li>Hematology </li></ul><ul><li>Infectious Disease </li></ul><ul><li>Immunology </li></ul><ul><li>Oncology </li></ul><ul><li>Ophthalmology </li></ul><ul><li>Pediatric </li></ul><ul><li>Pulmonary/ Respiratory </li></ul><ul><li>Rheumatology </li></ul><ul><li>Transplant </li></ul><ul><li>Vaccines </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    25. 25. Therapeutic Experience - Staff <ul><li>Cardiovascular – 75% of staff </li></ul><ul><li>Oncology – 75% of staff </li></ul><ul><li>Infectious Disease – 71% of staff </li></ul><ul><li>Ophthalmology – 69% of staff </li></ul><ul><li>CNS/Psychiatric – 52% of staff </li></ul><ul><li>Endocrinology – 49% of staff </li></ul><ul><li>Pulmonary/Respiratory – 18% of staff </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09 CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved.
    26. 26. Global and Large Trials- Examples CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09 Therapeutic Area Locations Project Size Angina Pectoris, Ph III N.America, Central and Eastern Europe 72 sites, 462 patients Acute Coronary Syndrome, Ph III N.America, Central and Eastern Europe 600 sites, 5500 patients Myocardial Perfusion Imaging, Ph III N. America, S. America, Central Europe 80 sites, 855 patients Prostate Cancer, Phase III N. America, Central and Eastern Europe 214 sites, 900 patients HIV Vaccine, Phase III N. America, Thailand 65 sites, 5300 patients Age-Related Macular Degeneration Phase III North America 145 Sites, 4443 Subjects
    27. 27. How Will We Manage Your Projects? CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09 Our Senior Project Managers can get the job done!
    28. 28. Example Project Team CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09 Sponsor (Client) Statistician ProTrials Project Manager Data Mgrs ProTrials Client Manager Data Management Vendor Lead CRAs and CR Assts Regional CRAs ProTrials Medical Monitor
    29. 29. Project Team Communication <ul><li>Effective communication is essential to a successful team </li></ul><ul><ul><li>Agree on best mode and flow of communication </li></ul></ul><ul><ul><li>Be aware of timelines and milestones </li></ul></ul><ul><ul><li>Provide open communication and feedback </li></ul></ul><ul><ul><li>Use teleconferences as effective tools for communication </li></ul></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    30. 30. Project Team Communication <ul><li>Communication Tools: </li></ul><ul><ul><li>Client status reports available at agreed upon frequency </li></ul></ul><ul><ul><li>Monitoring plan will be established prior to ProTrials study start </li></ul></ul><ul><ul><li>Communication plan, including issue escalation, will be developed during study startup </li></ul></ul><ul><ul><li>FAQs updated weekly </li></ul></ul><ul><ul><li>Team calendars to be distributed/posted at agreed upon frequency </li></ul></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    31. 31. Uniformity Within & Across Studies <ul><li>Focus on retaining team members throughout the life cycle of each study </li></ul><ul><li>Provide consistent information, tools and procedures </li></ul><ul><li>Document key information and procedures and disseminate in a timely manner to all team members </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    32. 32. Study Management Tools <ul><li>Including: </li></ul><ul><li>Clinical monitoring plan </li></ul><ul><li>Monitoring letter templates </li></ul><ul><li>Monitoring report templates </li></ul><ul><li>Monitoring worksheets </li></ul><ul><li>Regulatory forms/tracking </li></ul><ul><li>Contract templates </li></ul><ul><li>Enrollment tracking </li></ul><ul><li>Timeline tracking </li></ul><ul><li>Monitoring and visit report tracking </li></ul><ul><li>Study metrics report </li></ul><ul><li>Secure Project Intranet to facilitate team communication </li></ul><ul><li>Resourcing plans </li></ul><ul><li>Discrepancy resolution forms </li></ul><ul><li>Budget management and tracking </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    33. 33. Team Quality <ul><li>Quality CRA performance is ensured by: </li></ul><ul><ul><li>Providing a Monitoring Plan, Visit Report Writing/Review Guidelines at study startup </li></ul></ul><ul><ul><li>Timely review and feedback of critical documents, (e.g., visit reports, correspondence) </li></ul></ul><ul><ul><li>Contacting sites periodically regarding monitor performance. </li></ul></ul><ul><ul><li>Reviewing monitor metrics (e.g., # of patients monitored/visit, # of discrepancies generated/site) </li></ul></ul><ul><ul><li>Providing consistent and timely information to RCRAs: e.g., up-to-date & accessible FAQ log </li></ul></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    34. 34. Training <ul><li>In addition to training provided by Sponsors, we provide: </li></ul><ul><ul><li>One-on-one study orientation with each RCRA </li></ul></ul><ul><ul><li>Review of all study templates, timelines, study metrics, essential document collection/mgt, etc. </li></ul></ul><ul><ul><li>Ongoing training as projects change (e.g., amendments, procedures, etc.) </li></ul></ul><ul><ul><li>Training records of all CRO team members are maintained </li></ul></ul><ul><ul><li>Additional therapeutic training as needed </li></ul></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    35. 35. How Can We Grow with Your Project? <ul><li>Global Experience : International clinical trial management in Asia, Europe, and South America </li></ul><ul><li>CRO alliances : </li></ul><ul><ul><ul><li>Europe, including Eastern Europe </li></ul></ul></ul><ul><ul><ul><li>Latin America, including Mexico and South America </li></ul></ul></ul><ul><ul><ul><li>India and Australia </li></ul></ul></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    36. 36. Data Management <ul><li>Alliances: </li></ul><ul><ul><li>Pacific Data Designs (paper & fax) </li></ul></ul><ul><ul><li>Nextrials (EDC) </li></ul></ul><ul><ul><li>ACRS </li></ul></ul><ul><li>EDC Vendor Experience ( Phase II & III): </li></ul><ul><ul><li>Datatrak </li></ul></ul><ul><ul><li>Phase Forward </li></ul></ul><ul><ul><li>Nextrials/Prism </li></ul></ul><ul><ul><li>PHT </li></ul></ul><ul><ul><li>Omnicomm </li></ul></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    37. 37. What Sets Us Apart From The Competition? CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    38. 38. Experience and Retention <ul><li>Our Experience </li></ul><ul><ul><li>Project Managers: Average of 17 years of industry experience </li></ul></ul><ul><ul><li>Site Monitors: Average of 10 years of site management experience </li></ul></ul><ul><li>Our Retention </li></ul><ul><ul><li>90% + Employee Retention Rate </li></ul></ul><ul><ul><li>93% + Repeat Business Rate </li></ul></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    39. 39. Keys to Successful Teamwork <ul><li>Fully understanding goals and timelines </li></ul><ul><li>Efficient and proactive communications </li></ul><ul><li>Appropriate delegation of duties </li></ul><ul><li>Experienced and flexible staff </li></ul><ul><li>Proactive management of budget </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    40. 40. Quality Management <ul><li>CRA Quality is Critical </li></ul><ul><li>Oversight of staff by Line Manager & Project Manager throughout project </li></ul><ul><li>Two annual educational opportunities </li></ul><ul><ul><li>Offsite Training </li></ul></ul><ul><ul><li>Corporate Meeting including GCP training </li></ul></ul><ul><li>Internal ProTrials quality assessment visits every 1-2 years </li></ul><ul><li>Annual performance reviews include training needs assessments </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    41. 41. Quality Management - Audits <ul><li>We are audited every 1-2 months by prospective and active clients </li></ul><ul><li>Clients are welcome to co-monitor with our site monitors at any time </li></ul><ul><li>Sites managed by ProTrials (both domestic and international ) have undergone many FDA audits with no OAI findings </li></ul><ul><li>ProTrials headquarters has never been audited by the FDA or other regulatory agency </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    42. 42. ProTrials SOPs & Guidelines <ul><li>Audited by a number of clients with no significant findings </li></ul><ul><li>Reviewed annually and updated as required </li></ul><ul><li>Staff documents receipt and review of SOP/Guidelines and all updates </li></ul><ul><li>Staff training conducted at annual employee meeting, and by quiz with required score </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    43. 43. ProTrials Intranet – Client Access CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09
    44. 44. Why Choose ProTrials <ul><li>Experience </li></ul><ul><li>High Retention </li></ul><ul><li>Quality </li></ul><ul><li>Flexible </li></ul><ul><li>Cost effective </li></ul>CONFIDENTIAL Copyright @2001 PROTRIALS Corporation. All Rights Reserved. 06/07/09

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