About AVIGO

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 Because we offer a powerful mix of capabilities that enable our clients to achieve the transformative goals, and our core strengths and differentiators, enable us to deliver optimal time and process efficiencies while simultaneously reducing project costs and risk. 

Our strengths and differentiators include:

• An experienced cross-functional team that brings a strong understanding of the complexity and challenges of R&D in delivering a variety of innovative services and technology solutions. The team has
  • A blend of research and regulated systems and technology skills.
  • Breadth and depth of experience with domain-specific tools, technologies and processes.
  • Hands-on experience with R&D systems.
  • Expertise in 21 CFR Part 11, cGxP, HIPAA and related regulations.
• The capabilities to perform outsourced services, and if required, implement a rapidly scalable operational capability.
• A phased-methodology to solution development that, coupled with an integrated project management approach and integrated quality compliance, ensures process rigor and discipline while minimizing project risks.

The Avigo staff has deep domain experience in the life sciences and key staff members over the course of their careers have founded/established biopharmaceutical and related CRO/technology companies, and helped establish or define a number of industry standards. As an example, our team comprises of senior members such as:

• Satish Tadikonda (Managing Partner) is the founder of 4 life sciences technology companies and has over 22+ years of relevant industry experience. In addition to conceptualizing and leading the development of industry-leading software products in structured content management, clinical trial optimization and regulatory information management, electronic data capture and related areas, Satish has led or participated in over 350+ strategy and implementation projects, including those for leading pharma, CROs and medical device companies such as Sanofi/Genzyme, Novartis, Mylan, Millennium/Takeda, Hospira, Quintiles, Parexel etc. He has been an active participant in helping develop a number of industry standards (DICOM, CDISC, SPL/PLR, RPS, eStability and other HL7 standards). See https://www.linkedin.com/in/satish-tadikonda-195611108 
• Sheldon Borkin (CTO) was one of the earliest employees of WebMD (from startup to $1B/yr revenue) and as Chief Security Officer was responsible for WebMD’s overall information security and HIPAA compliance. He also led the clinical applications group in developing clinical trials and disease management systems with pharma & CRO partners, and was chief architect for several CMS Medicare systems. He led creation of the successful M&A-driven growth plan for the $600M Emdeon division. Dr. Borkin authored a book on semantic databases, was co-author of the SANS book on HIPAA Security, and taught at MIT’s Sloan School. See https://www.linkedin.com/in/sheldonborkin

In addition to experienced senior management, the Avigo team consists of a mix of domain experts in the following:

• Business Analysis and Strategy Development, Support and Maintenance
• Software Development/Implementation and Outsourced Development and Services
• Clinical and Regulatory Processes, Systems and Functions
• Reporting and Analytics
• Quality Compliance, incl. Computer Systems Validation

Avigo’s core offerings are based on the practical implementation of integrated solutions that enhance decision-making capabilities in R&D. At a broad level, our offerings encompass requirements definition, product strategy, system architecture and design, development and integration, and operations support solutions. Specific areas of expertise include the following:

• Patient recruitment and engagement technologies
• Clinical registries, including QI registries, and Patient communities
• Clinical trial protocol optimization and clinical trial data management, including CDISC transformations
• Regulatory information management, including management of HA interactions , CMC change assessments, contacts/commitments, submissions and registrations
• IDMP data rationalization 
• Drug Safety and Labeling solutions
• Regulated document management
• Pharmaceutical R&D systems management
• 21 CFR Part 11, HIPAA and cGxP compliance