Introduction to Capabilities

1. Introduction to Capabilities Approach and Service Offerings

2. Introduction • Wability is a Business and Technology Management Consulting firm with extensive track records in the development and deployment of solutions for a wide range of clients within many industry verticals. • Our services support strategies that optimize the investment and minimize time to market.

3. Background • We are a single-source management consulting firm that helps clients bridge the gap from strategy to implementation at any point in the business lifecycle • We are committed to providing clients with strategic solutions that link organizational initiatives and technology to the overall business strategies

4. Our Mission Statement “To Continually earn the fierce loyalty of our clients” To accomplish our mission, we focus on: • Providing consistently high-quality service to every project we conduct. • It means standardizing, measuring, and continuously improving our processes. • It means extracting local knowledge and resources from all over. • It means retaining thought leaders and best in class consultants in our fields of expertise. • It means committing our senior management to be heavily involved in client relationships.

5. What Makes us unique Wability is distinguished by our company-wide commitment to the success of every one of our projects. Our project managers are supported by a global standardized infrastructure, local country experts and senior management involvement to ensure the success of each of your clinical trials. That's The Project Assurance difference from Wability • Reliable Service Delivery • Program Management Expertise • Easy Access to Global Knowledge • Involved Senior Management

6. Reliable Service Delivery • WABILITY Management System is an organization wide commitment to standardize processes and measure performance throughout our organization. • We track more than ten project performance metrics every month, and we use these metrics to drive continuous improvement efforts. • We utilize a standardized, global IT infrastructure to facilitate communication, access to study information, and flexible deployment of resources across locations. • Our training programs allow our employees for a global exchange of ideas and best practices.

7. Involved Sr.Management • Our Project Managers serve as the hub of our organization, and they are empowered to deliver additional executive involvement in projects when necessary. • A Vice President is assigned to and responsible for the success of every project. The VP reviews the status of each project, in detail, two times per month and authorizes actions • Executives and managers provide clients with strategic expertise necessary to effectively plan complex clinical development programs that are expeditious, accurate, and cost-efficient. • WABILITY attracts, trains and keeps the industry’s brightest people who are excited about helping the medical community find new cures. And the success is contagious.

8. Industry Focus We provide solutions to the following industry segments: • Pharmaceutical and Biotechnology • Financial Services to include: • Capital Markets • Consumer and Retail Banking • Investment Banking • Insurance • Consumer Products • Federal and State Governments

9. Business and Technology • Data Security and Management • Business Intelligence • CRM (Customer Relationship Management) • System Development • Data Integration • Document Management • Productivity and Performance Management • Business Strategy and Planning • Business Process Design Capability • Risk Management • SOX Compliance • Business Continuity and Disaster Recovery • Quality Assurance • Six Sigma Business Processes Business Change Information Technology Organization

10. Business Strategy Corporate visioning Opportunity identification, prioritization, and portfolio selection Market/competitive analysis Portfolio design & management Asset & capability assessment Resource investment allocation M&A planning Budget formulation & review Budget planning Organization & Process Organizational structure Business process redesign Workflow automation Supply chain optimization Execution Management Execution strategy Team assembly RFP development Budget management Solutions- Strategy

11. Solutions- Business We offer services which are designed to improve executive focus, improve communications, and identify and improve performance and process challenges. • Six Sigma • Risk Management • Business Process Design and Analysis • SOX Compliance • Business Continuity

12. Solutions - Critical We design and implement solutions with the enterprise in mind through: • Information Security • Customer Relationship Management (CRM) • Document Management • Business Intelligence • Data Integration • Productivity and Performance Management

13. Service Offerings Wability’s Pharmaceutical Service Offerings • Clinical Development • Safety Surveillance & Pharmacovigilance • Clinical Data Management • Medical Writing • Medical Affairs & Regulatory Services • Quality Assurance

14. Wability’s Advantages • We have been involved with over 10 Cardiovascular trials, 23 CNS trials, 11 Oncology trials, and 18 Respiratory trials in our largest therapeutic areas. • We have senior-level drug development experts that plan drug development strategy, write Investigational New Drug (IND) and Clinical Trial Exemption (CTX) applications, design studies, and defend plans and submissions to regulatory authorities. • We select our investigators from a large investigator database that has up-to-date recruitment metrics from recent trials.

15. Wability’s Advantages • Our strategic pharmaceutical consulting services provides our clients with: • Quality-assured, focused therapeutic and regulatory expertise. • State-of-the-art business and technology services during preclinical and clinical development without the concern of fixed costs. • We assist our clients by helping them to effectively manage their pipeline by supporting flexible R&D strategies and effective marketing strategies, rollouts and analyses for approved therapies.

16. Wability’s Advantages • Our offices are located in four countries that have access to qualified sites that can deliver higher and more reliable patient recruitment rates. • Our worldwide offices are intimately familiar with local regulatory requirements for start-up. Their knowledge of the investigational site community enables them to identify the best investigators and recruit the right patients for each trial. • We work with opinion leaders in every country to identify sites and assess feasibility.

17. Clinical Development II. Clinical Development Capabilities • Wability delivers the insight and expertise of clinicians, regulators, scientists, and health economics experts with competencies that cover every aspect of the drug development process. Our services are available across multiple therapeutic specialties. • Wability takes innovative approaches to provide high quality service within budget by challenging assumptions about traditional clinical trial design and management. Throughout the company, SOPs, communications systems and high standards of quality, will ensure excellence.

18. Clinical Development II. Clinical Development Capabilities • Phase II – III Studies • Protocol Design and Writing • Study Sites Initiation • Investigators Meeting • Site Monitoring and CRA Support • Data Management • Clinical Safety / SAE review, evaluation and reporting

19. Safety Surveillance IV. Safety Surveillance Capabilities Wability understands that our clients have an enormous responsibility to ensure the safety of those who use their products. Spontaneous AE report collection, processing and regulatory reporting. Each program is customized and can include any or all of the following: • Receiving AE reports from healthcare professionals and from customers • Triaging calls such as product complaints back to the client side • Crisis Response/Crisis Management

20. Safety Surveillance • Our clinicians will work with you to prepare crisis management strategies. These strategies allow for rapid responses during periods of AE reporting or product withdrawal. • Our activities range from preparation of standard responses to health care professionals and consumers to proactive epidemiological evaluation. • On-site safety surveillance support Epidemiological Analysis The epidemiological components of a surveillance program include:

21. Safety Surveillance • The development of strategies for signal detection • Analysis of external data sources • The creation of registries for continuous safety monitoring of one or more of your products Wability provides medically qualified staff directly to clients to assist in safety surveillance efforts: • Providing medical reviews and the processing of expedited FDA 3500A and CIOMS I reports. • Reviewing legal briefs to identify potential serious events and addressing all incoming telephone inquiries.

22. Clinical Data Management V. Clinical Data Management Capabilities • Modern technology and innovations to data management and biometric processes are transforming and expediting how clinical Trials are conducted and the ways in which the resulting information is used for regulatory submissions. Service Areas include: • Protocol design and review • Randomization schedules • Case Report Form (CFR) design & review • Database design and Data entry • Data validation and verification • Statistical design and programming • Electronic data transfer • Clinical trial reports

23. Medical Writing VI. Medical Writing Capabilities Wability has expert medical writers on staff with the ability to prepare a large variety of documents including: • Investigator’s brochures • Protocols • Statistical reports • Clinical study reports • Integrated Summaries of Efficacy • Integrated Summaries of Safety • Clinical expert reports • Publications • INDs

24. Medical Affairs VII. Medical Affairs Services • We provide our clients with full- service Medical Affairs offerings, bringing innovation, integration and experience to drug development. •   We ensure persuasiveness and high level of credibility through proper interpretation of the data generated, correct positioning of the products in relation to current therapeutic options and rewarding contacts with opinion leaders

25. Medical Affairs Phase IV • These types of studies are unique since they are designed to handle commercialization issues. • Wability offers extensive experience in the Design and execution of these specialized trials. Our expert clinicians will work with your team in order to create unique solutions to meet your specific needs.

26. Medical Affairs Wability understands how to increase the effectiveness of your sales force, optimizing their participation in the outcome of the study. Some of the sales force participation programs we develop include the following elements: • The development of dedicated training materials for the field sales force • The establishment of call-centers dedicated to addressing study-related questions from the field sales force • The development of activity-based incentives

27. Medical Affairs Medical Affairs: Service Offerings • Competence and dedication- 7/24 support. Support from highly qualified and experienced professionals • Strong commercial awareness and the ability of dealing with complex scientific issues • Expertise in interacting with the FDA • An adaptable and versatile approach to individual requirements • Comprehensive services with frequent status reports and deadlines • Monitoring of customer satisfaction

28. Medical Affairs Medical Affairs: Service Offerings • Phase IV Studies • Professional Education Programs • Publications • Speakers Programs • Outcomes Research • Advisory Board • Medical Science Liaisons • Medical Information

29. Regulatory Affairs Regulatory Affairs Capabilities • Regulatory Strategies • NDA and Pharmaceutical documentation • Clinical documentation (including ISS and ISE) • Expert reports and summaries • Submission through authorization • Regulatory consultancy for most regulatory issues • Investigator’s drug brochures • Clinical trial applications (CTX / IND) • Clinical study reports, manuscripts and PSUR • GCP Compliance

30. Quality Assurance III. Quality Assurance (QA) Capabilities Wability provides clients with a high level of expertise in planning and administering QA services. Every QA program adheres to the most rigorous standards and specifications. Some of the services we provide are: • ISS / ISE report audits • Protocol reviews • GCP compliance study reviews • Computer system validation reviews • Database audits

31. Quality Assurance Quality Assurance (QA) Capabilities • SAE reconciliation audits • Internal process audits • Tables / Listing audits • Investigator site audits • Statistical reports audits • Vendor assessments • SOP/ SSP development and administration

32. Sample Clients

33. Our Value • Unmatched expertise. Our consultants have unparalleled skill sets with an average of 10 years experience in their areas of expertise. • No learning on our client’s dime!--- Uniquely qualified consultants are assigned to each project based on that project’s specific requirements. • Innovative solutions designed to provide our clients with a profitable, long-term competitive advantage. • Quality assurance and client satisfaction are assured by our top executives. • Superior client references