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 medicine, drug discovery and development, pre-clinical and clinical trials, laboratory developed tests (LDTs), medical device development, managed care reimbursement, FDA and CLIA regulatory affairs, marketing communication, finance strategy, and clinical operations.
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.
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.