Expert Advisors



Expert guidance, consulting, and resources for growing personalized medicine companies.

Double Helix expert advisors assist personalized medicine, biotechnology, diagnostic laboratory, healthcare, and life-science companies with a range of scientific, business, reimbursement, and regulatory challenges.  Our consulting and advisory services span the entire development life-cycle from research through development to commercialization.

Double-Helix® Expert Advisors know what it takes to get diagnostic and precision medicine products reimbursed by insurance and how to design clinical trials, show clinical utility, and package health economic data for successful payment.

Our consultants advise Software-as-a-Service (SaaS) and Mobile Application providers who market and sell their products to the pharmaceutical, biopharma, laboratory, and healthcare market to meet customer expectations as well as HIPAA, FISMA, FDA and related regulatory requirements.

Our network of experts have extensive industry experience in personalized medicine and precision medicinedrug discovery and development, pre-clinical and clinical trials, laboratory developed tests (LDTs)medical device development, managed care reimbursementFDA and CLIA regulatory affairs, marketing communication, finance strategy, and clinical operations.

Expert Advisors and Areas of Expertise

Our Double-Helix team of advisors can address the following areas for your growing personalized medicine business:Expert Advisors

STRATEGIC

  • Reimbursement, Billing, Coding, and Pricing Strategy
  • Medical Product and Marketing Strategy
  • International Business Development
  • Clinical Operations, Protocol Design, CRO Selection
  • Research and Development

INFORMATION TECHNOLOGY

  • Enterprise Architecture Assessment
  • Network and Storage Architecture
  • High Performance Computing (HPC)
  • Cloud Technology, SaaS, and Amazon Web Services (AWS) Strategy
  • See also our Information Technology practice page

LABORATORY

  • Laboratory Automation
  • Laboratory Information Management Systems (LIMS)
  • Statistical Process Control (SPS)
  • Customer Service and Billing Operations

DATA ANALYSIS AND MANAGEMENT

  • High Performance Computing (HPC)
  • Business Intelligence and Dashboarding
  • Bioinformatics and Biostatistics
  • Next Generation Sequencing Data Management

QUALITY AND COMPLIANCE

  • CLIA/CAP Compliance
  • Quality Systems Regulations (QSR) Part 820 and ISO 13485
  • CFR 21 Part 11 Compliance
  • FISMA, FEDRAMP, PCI Compliance
  • Document Control and Management

INFORMATION PRIVACY AND SECURITY

  • HIPAA and HITECH Policy and Procedure Development
  • Privacy-By-Design and Security-By-Design
  • Vendor Assessment and Audit
  • See also our Privacy and Security practice page

FINANCE

  • Finance Strategy and Operations
  • Sarbanes-Oxley (SOX) IT Controls
  • Enterprise Resource Planning (ERP) Selection

Real World Experience

Our advisors have taken products successfully through personalized medicine Clinical Trials, New Drug Applications (NDAs), Medical Device Pre-Market Approval (PMAs), 510(k) Clearances, InVitro Diagnostics, CLIA “Home-Brew” LDT Diagnostics, and CAP inspection processes.

Our advisors have worked with multiple Laboratory Information Management Systems (LIMS), Document Control systems, and are well versed in Quality System Regulations (QSR), ISO 13485, and Food and Drug Administration (FDA) requirements, and have developed end-to-end Privacy and Security programs.

Our expert advisors have direct experience working with diverse insurance providers, international laboratory partners, hospital systems, and medical practices.

Our technical advisors have been part of real-world implementation projects that transform paper-based and manual processes to more efficient electronic systems, build scalable cloud solutions, and automate laboratory and financal processes.

Fractional Leadership

Double Helix expert personnel are able to serve your growing organization as a virtual or fractional CMO, CSO, CIO, CTO, CFO or other officer providing strategic direction, co-ordinate resources, and at a fraction of the cost of a full-time officer.

Leveraging a Double Helix fractional advisor can help you build your product strategy, go to market, provide input to near term strategy decisions, and help plan and budget for the future.