We Make Real World Data Work
Our passion is optimizing RWD/RWE documents and operations to get the best results for patients and their families. We are so excited about the possibilities of this nascent industry for its potential to improve the lives of our fellow humans!
Our Product:
Kinetika
Automated Medical Writing Tool
Asclepia’s software, Kinetika, is a technology solution that merges RWD/RWE with health agency reporting. Kinetika helps you create more accurate documentation to produce more meaningful data. We create the documents that help you focus on leveraging real-world healthcare data to support clinical research and drug development activities.
Additional Services
RWD/RWE Operations
The nuts and bolts of our team’s work-a-day life is creating and instituting processes. As such, Asclepia has developed scalable and replicable RWD procedures and systems which parallel the clinical trial management processes and support complex RWD studies.
RWD/RWE Medical Writing
Our consultants take a tailored approach, merging specifications of the RWD/RWD industry to the needs and regulatory requirements of the pharma industry. We work iteratively with your team in a timely manner to hone your messaging and finalize your documents.
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Real World Data Strategy and Operations
Amanda is the Managing Director of Quanten, LLC. She is a consultant with industry-leading real-world data and research companies as well as large pharmaceutical companies and biotechs, specializing in designing scalable and replicable RWD processes and systems, assessing and qualifying fit-for-purpose data sources to answer specific research questions, and developing regulatory-facing RWD documentation.
Prior to establishing Quanten in 2021, Amanda was a Director in Parexel’s Scientific Data Organization leading strategy around complex and innovative RWD study types like hybrids and external control arms, as well as creating and instituting processes around these and other activities. She started and led multiple innovation projects leading to the development of new products and services.
Amanda got her start in RWD at Anolinx, a niche real-world CRO focused on deep secondary data. Prior to her real-world focus, she worked as a medical writer on a wide range of projects, including CDC’s Field Epidemiology Training Program.
Amanda has a BA from the University of North Carolina at Chapel Hill.
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Regulatory and RWD/RWE Writing
In addition to being a Founder of Asclepia, Catherine is the owner of Lareau Consulting through which she has worked with Big Pharma, as well as midsized and start-up life science companies, writing their clinical- and FDA-facing documents. Currently, Catherine is the Head of Regulatory Writing for the biosimilar company, Alvotech. In the past, she has served as President and on the Board of Directors for her local chapter of the American Medical Writers Association (AMWA).
Catherine has over 20 years of experience in the life sciences with a focus in regulatory writing. She has authored or contributed to a wide range of documents across the full span of the drug development life cycle, including: INDs and NDAs, including BLAs, 505(b)(2), sNDAs, + ANDAs (Module 2.2: Introductions; 2.5: Clinical Overviews; 2.7: Summaries of Clinical Efficacy, Summaries of Clinical Safety; ISS, ISE, and ISIs; literature reviews, briefing documents, annual reports, DSUR, PBRER, PSUR, clinical protocols, Investigator’s Brochures, clinical study reports (CSRs), clinical development plans (CDPs), manuscripts; pediatric study plans, package inserts, physician guidance, product labeling, Risk Evaluation and Mitigation Strategies (REMS), Risk Management Plans (RMPs), clinical outcome assessment (COA) dossiers (PRO and ClinRO), and patient safety narratives. She has also developed SOPs, templates, and training materials for multiple teams.
Catherine has applied this deep grounding in traditional clinical trial and submission dossier processes and documents to developing reproducible and scalable approaches for complex RWD studies. Catherine and Amanda together have published analyses of RWD protocol standard practices and have been invited to author work on RWD documentation for ISPOR’s Value & Outcomes Spotlight based on contributions to the field as a result.
Catherine holds an MS in Epidemiology from the University of Virginia and a BA in English from the College of William and Mary.