Life Sciences & Research Institutions
We make your regulatory data submission compliant to FDA accepted standards for precision medicine and allow you to continuously monitor & interact virtually with your patients.
More than ever in this period of COVID-19 pandemic, lifesciences are under tremendous pressure to develop drugs & monitor post-market safety & efficiency faster at a lesser cost
Massive Genomic Datasets
Need for cost control
Regulators need high quality data
Looming commercial timelines
However, error-prone complex big datasets, late data reconciliation, uncertainty of regulatory requests & feedback bring significant risks to life sciences regulatory submissions in terms of cost overrun & time-to-market.
Similar risks exist in the post-market surveillance space where one-off real-world evidence studies are expensive, slow to produce results (which are not reused) & limited in the insight they provide as they only rely on only one data type such as EMRs or PROs.
By establishing patient-driven data networks using our HIVE & Virtual Studies technology, you will have continuous feeds of high-quality real-world data from active patients & clinicians. For your products in clinical research stage, you will gather valuable insights in disease epidemiology, standards of care, patient segments. For those on the market, you will receive live feeds of real-world evidence for safety & efficacy monitoring & access a community of patients ready to participate in your research projects and use your digital services & therapeutics.
HIVE Submission Dry-Run
Because our HIVE is the only authorized tool used by the U.S. Food & Drug Administration to conduct regulatory data reviews involving Next Generation Sequencing, it allows you to conduct the same data & analytics quality controls performed by the FDA. By adopting HIVE, you will considerably de-risk your submission and avoid lengthy regulatory loops with the FDA when responding reactively to their enquiries on your genomic data and analytics.
Inclusive of all data types.
Our HIVE Submission Dry-Run offering provides a blinded, comprehensive analysis & problem determination of your clinical trial data set, including your STDM files, images, lab results, genomic data and algorithms used to analyze your data sets.
Alignment for Speed & Accuracy.
Because HIVE is used by the FDA to conduct their regulatory analysis on your data, you will benefit by using the same Quality Control checks, ontology mapping, data provenance frameworks, analytics library and other tools used by the FDA to perform its quality control on NGS based data submissions.
Beyond retrospective quality control, HIVE also allows you to detect potential issues such as patient safety issues that would go undetected before you submit and that the FDA would identify during the regulatory review.
To even further align with the FDA, HIVE can also package your NGS data set in accepted FDA standard formats such as the HIVE Pack & Biocompute.
Dr. Vahan Simonyan
Our regulatory bioinformatics team led by Dr. Vahan Simonyan, former director of bioinformatics R&D at the FDA & co-author of HIVE, will help you define your verification protocol, select the appropriate tools in HIVE and train you to use HIVE for running the analyses. We will also provide a comprehensive documentation for each issue and provide you a set of actionable actions to solve them.