Introduction to CapabilitiesIntroduction to Capabilities
Approach and Service OfferingsApproach and Service Offerings
WABILITYKnowledge & Experience
Wability is a Business and
Technology ManagementConsulting firm with
extensive track records in the development
and deployment of solutionsfor a wide range of clients
withinmany industry verticals.
Our services support strategies that optimize the investment and minimize time to market.
Introduction
WABILITYKnowledge & Experience
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
WABILITYKnowledge & Experience
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.
WABILITYKnowledge & Experience
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
WABILITYKnowledge & Experience
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.
WABILITYKnowledge & Experience
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.
WABILITYKnowledge & Experience
Industry Focus
We provide solutions to the followingindustry segments:
1. Pharmaceutical and Biotechnology
2. Financial Services to include:
Capital Markets Consumer and Retail Banking Investment Banking Insurance
3. Consumer Products4. Federal and State Governments
WABILITYKnowledge & Experience
Business and Technology
Data Security and Management
Business Intelligence
CRM (Customer Relationship Management)
System Development
Data Integration
Document Management
Productivity and Performance Management
Business Processes
BusinessChange
OrganizationInformationTechnology
Business Strategy and Planning
Business Process Design Capability
Risk Management
SOX Compliance
Business Continuity and Disaster Recovery
Quality Assurance
Six Sigma
WABILITYKnowledge & Experience
Solutions- Strategy
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
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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
WABILITYKnowledge & Experience
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
WABILITYKnowledge & Experience
Service Offerings
Wability’s Pharmaceutical Service Offerings
Clinical Development
Safety Surveillance & Pharmacovigilance
Clinical Data Management
Medical Writing
Medical Affairs & Regulatory Services
Quality Assurance
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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.
WABILITYKnowledge & Experience
Our strategic pharmaceutical consulting services provides our clients with:
A. Quality-assured, focused therapeutic and regulatory expertise.
B. 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.
Wability’s Advantages
WABILITYKnowledge & Experience
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.
WABILITYKnowledge & Experience
Clinical Development
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.
II. Clinical Development Capabilities
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Clinical Development
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
II. Clinical Development Capabilities
WABILITYKnowledge & Experience
Safety Surveillance
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
IV. Safety Surveillance Capabilities
WABILITYKnowledge & Experience
Safety Surveillance
A. 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.
B. 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:
WABILITYKnowledge & Experience
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.
WABILITYKnowledge & Experience
Clinical Data Management
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
V. Clinical Data Management Capabilities
WABILITYKnowledge & Experience
Medical Writing
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
VI. Medical Writing Capabilities
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Medical Affairs
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
VII. Medical Affairs Services
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Medical Affairs
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.
Phase IV
WABILITYKnowledge & Experience
Medical AffairsWability 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
WABILITYKnowledge & Experience
Medical Affairs
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
Medical Affairs: Service Offerings
WABILITYKnowledge & Experience
Medical Affairs
Phase IV Studies
Professional Education Programs
Publications
Speakers Programs
Outcomes Research
Advisory Board
Medical Science Liaisons
Medical Information
Medical Affairs: Service Offerings
WABILITYKnowledge & Experience
Regulatory Affairs
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
Regulatory Affairs Capabilities
WABILITYKnowledge & Experience
Quality Assurance
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
III. Quality Assurance (QA) Capabilities
WABILITYKnowledge & Experience
Quality Assurance
SAE reconciliation audits
Internal process audits
Tables / Listing audits
Investigator site audits
Statistical reports audits
Vendor assessments
SOP/ SSP development and administration
Quality Assurance (QA) Capabilities
WABILITYKnowledge & Experience
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