Introduction to Capabilities Introduction to Capabilities Approach and Service Offerings Approach...

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


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


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.


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


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.


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.


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


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


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


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


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


Service Offerings

Wability’s Pharmaceutical Service Offerings

Clinical Development

Safety Surveillance & Pharmacovigilance

Clinical Data Management

Medical Writing

Medical Affairs & Regulatory Services

Quality Assurance


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.


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.




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.



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



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


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


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:


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.


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


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


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


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


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


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


Medical Affairs

Phase IV Studies

Professional Education Programs

Publications

Speakers Programs

Outcomes Research

Advisory Board

Medical Science Liaisons

Medical Information

Medical Affairs: Service Offerings


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


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


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


Sample Clients


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

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