Gen Capabilities Pro Trials Presentation.0808

Who We AreHow We Can Support your Project

2008

ProTrials’ History

• Founded in 1996 by two CRAs with 18 years of clinical operations experience between them

• Both had managed and worked with CROs

• Commitment to provide better service through:

• Clinical Operations Experience

• Flexibility

• Cost effectiveness

• Honest communication with clients and staff

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ProTrials’ Staff

• Set precedent of hiring experienced staff

• Monitors have an average of 10 years of monitoring experience

• Project Managers have an average of 17 years of industry experience

• Employee retention rate over 90%

• Clinical employees average 4 years at ProTrials – several over 10 years

ProTrials’ Services

• We focus on what we know

• Internal – Clinical Operations

• Clinical Project Management

• Site Management and Monitoring

• Vendor Management, etc.

• External – Partnerships

• EDC and other vendors

• International clinical operations partners

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Our Mission

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

ProTrials Today

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Our Offices

Corporate Office

444 Castro Street, Ste 900Mountain View, CA94041

Ph: (650) 864-9180Fx: (650) 864-9190

East Coast Office

218 Cassidy LaneChapel Hill, North Carolina27516

Ph: (919) 960-9370Fx: (919) 967-1324

www.protrials.com

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Our Organization

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Role Descriptions• Project Manager: Primary contact with client,

overall responsibility of ProTrials team management, tracking timelines, completing client status reports

• Client Manager (Nonbillable): Global communication with sponsor regarding scope of work, sponsor expectations, project team performance

• Line Manager (Nonbillable): Primary HR responsibilities for direct reports, conducts annual reviews, assesses training needs, project work load

Our Staff

• 75 Full time employees located in the US

• 22 Subcontractors located in the US and Canada

• 200+ Staff available through our Global Partners in:

• Europe (Central and Eastern)

• Latin America (Central and Southern)

• India

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Staff Locations - US

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Strategically located to optimize cost effectiveness

N.Carolina: 14 employeesCorporate Headquarters:

Mountain View, CA

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Staff Locations in Other Countries

Full Service Outsourcing

• ProTrials has been successful working together with partners to provide a full service option to our clients

• ProTrials can work with our established partners or can work with partners of your choosing

• ProTrials will ensure:

• Seamless communication

• Efficient project management

• Consistent metric collection

• Aligned goal orientation

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Our Key Services

• Project management

Team management

Vendor management

Recruitment management

Contract and budget management

• Site monitoring

• Medical monitor support

• Central storage of study documents

• Investigator payments

• Investigator meetings

• Study tool development

• Protocol and CRF development

• Secure client project portal

• Quality assurance auditing

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Expanded Services

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•ProTrials •Strategic Alliances

• Clinical Operations Specialists• Project management

• Site monitoring

• Medical Monitor support

• Recruitment, etc…

• Data Management

• Global Monitoring Partners

• IVRS, Central Lab

• Regulatory, etc…

Original Goals Have Been Maintained:• Experience

• Staff continues to have a high level of experience

• Flexibility

• Can provide entire clinical team, or individual staff

• SOPs, forms, and procedures tailored to project

• Cost-effectiveness

• All charges and costs transparent to Client

• Honest communication with Clients and Staff

• Clear communication at all stages of project

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Our Core Values

• 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.

• 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.

• 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.

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Our Core Values

• 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.

• 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.

• 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.

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Community Commitment

• Certified Women-Owned Business

• Certified Green Business in Santa Clara County

• Provide 8 hours annually of paid community service time to employees

• Annual corporate charity contributions based on employee recommendations

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ProTrials’ Experience

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Industry Experience

• ProTrials Industry Experience:

• Staff Experience in all Phases of ResearchPh I - 46%, Ph II - 77%, Ph III - 94%, Ph IV - 49%

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Client Experience – Partial List• Acambis• Adiana• Aradigm• BAS Medical• BioMarin• Chiron (Novartis)• CV Therapeutics• Epix Pharmaceuticals• Fziomed• Fibrogen• Genentech• Guidant (Abbott Vascular)

• Intermune• Infinity Pharmaceuticals• Medivation• NeoRx (Poniard)• Novacea• Point Biomedical• Proteolix• Roche• Sinus Pharma• Spinal Motion• Tercica• VaxGen

Therapeutic Experience - ProTrials

Total # of Protocols managed to date =

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Therapeutic Experience – ProTrials

• Analgesia

• Cardiovascular

• CNS

• Dermatology

• Endocrinology

• Gastroenterology

• Genitourinary System

• Hematology

• Infectious Disease

• Immunology

• Oncology

• Ophthalmology

• Pediatric

• Pulmonary/ Respiratory

• Rheumatology

• Transplant

• Vaccines

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Therapeutic Experience - Staff

• Cardiovascular – 75% of staff

• Oncology – 75% of staff

• Infectious Disease – 71% of staff

• Ophthalmology – 69% of staff

• CNS/Psychiatric – 52% of staff

• Endocrinology – 49% of staff

• Pulmonary/Respiratory – 18% of staff

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Global and Large Trials- Examples

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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 DegenerationPhase III

North America 145 Sites, 4443 Subjects

How Will We Manage Your Projects?

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Our Senior Project Managers can get the job done!

Example Project Team

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Sponsor (Client)

Statistician

ProTrials

Project Manager

Data Mgrs

ProTrials

Client Manager

Data Management

Vendor

Lead CRAs and

CR AsstsRegional CRAs

ProTrials Medical

Monitor

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Project Team Communication

• Effective communication is essential to a successful team

• Agree on best mode and flow of communication

• Be aware of timelines and milestones

• Provide open communication and feedback

• Use teleconferences as effective tools for communication

Project Team Communication• Communication Tools:

• Client status reports available at agreed upon frequency

• Monitoring plan will be established prior to ProTrials study start

• Communication plan, including issue escalation, will be developed during study startup

• FAQs updated weekly

• Team calendars to be distributed/posted at agreed upon frequency

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Uniformity Within & Across Studies

• Focus on retaining team members throughout the life cycle of each study

• Provide consistent information, tools and procedures

• Document key information and procedures and disseminate in a timely manner to all team members

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Study Management Tools

Including:• Clinical monitoring plan

• Monitoring letter templates

• Monitoring report templates

• Monitoring worksheets

• Regulatory forms/tracking

• Contract templates

• Enrollment tracking

• Timeline tracking• Monitoring and visit report

tracking• Study metrics report • Secure Project Intranet to

facilitate team communication• Resourcing plans• Discrepancy resolution forms• Budget management and

tracking

Team Quality

• Quality CRA performance is ensured by:• Providing a Monitoring Plan, Visit Report

Writing/Review Guidelines at study startup

• Timely review and feedback of critical documents, (e.g., visit reports, correspondence)

• Contacting sites periodically regarding monitor performance.

• Reviewing monitor metrics (e.g., # of patients monitored/visit, # of discrepancies generated/site)

• Providing consistent and timely information to RCRAs: e.g., up-to-date & accessible FAQ log

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Training• In addition to training provided by Sponsors, we

provide:

• One-on-one study orientation with each RCRA

• Review of all study templates, timelines, study metrics, essential document collection/mgt, etc.

• Ongoing training as projects change (e.g., amendments, procedures, etc.)

• Training records of all CRO team members are maintained

• Additional therapeutic training as needed

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How Can We Grow with Your Project?

• Global Experience: International clinical trial management in Asia, Europe, and South America

• CRO alliances:• Europe, including Eastern Europe

• Latin America, including Mexico and South America

• India and Australia

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Data Management• Alliances:

• Pacific Data Designs (paper & fax)

• Nextrials (EDC)

• ACRS

• EDC Vendor Experience (Phase II & III):• Datatrak

• Phase Forward

• Nextrials/Prism

• PHT

• Omnicomm

What Sets Us Apart From The Competition?

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Experience and Retention• Our Experience

• Project Managers: Average of 17 years of industry experience

• Site Monitors: Average of 10 years of site management experience

• Our Retention

• 90% + Employee Retention Rate

• 93% + Repeat Business Rate

Keys to Successful Teamwork

• Fully understanding goals and timelines

• Efficient and proactive communications

• Appropriate delegation of duties

• Experienced and flexible staff

• Proactive management of budget

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Quality Management

CRA Quality is Critical

• Oversight of staff by Line Manager & Project Manager throughout project

• Two annual educational opportunities• Offsite Training

• Corporate Meeting including GCP training

• Internal ProTrials quality assessment visits every 1-2 years

• Annual performance reviews include training needs assessments

Quality Management - Audits• We are audited every 1-2 months by

prospective and active clients

• Clients are welcome to co-monitor with our site monitors at any time

• Sites managed by ProTrials (both domestic and international ) have undergone many FDA audits with no OAI findings

• ProTrials headquarters has never been audited by the FDA or other regulatory agency

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ProTrials SOPs & Guidelines

• Audited by a number of clients with no significant findings

• Reviewed annually and updated as required

• Staff documents receipt and review of SOP/Guidelines and all updates

• Staff training conducted at annual employee meeting, and by quiz with required score

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ProTrials Intranet – Client Access

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Why Choose ProTrials

• Experience

• High Retention

• Quality

• Flexible

• Cost effective