Frequently Asked Questions

We love questions! Below are answers to the common ones people have as they start using our platform. Leave us a Message if you don't find what you need.

Platform

1.
Which standard drug models are available with free individual accounts?
Clinically validated standard models that do not require PHI are included with free individual accounts. This typically includes intravenous and formulation-specific oral administration for several drug classes including antibiotics commonly administered around the world (such as Amikacin, Cefepime, Ceftriaxone, Gentamicin, Meropenem, Piperacillin/Tazobactam, Tobramycin, Vancomycin & Voriconazole), and other drug classes such as antimetabolites, anti-seizure, immunosuppressants etc. (e.g. Phenytoin, Tacrolimus, Methotrexate, Adalimumab and Infliximab) -- see relevant publications. To use any of these, log in to your account, click “Drug Dosing” and select the drug molecule.
2.
Which simulation methods are available with individual accounts?

Individual accounts get free access to modeling methods that do not need PHI (Protected Health Information as defined by HIPAA). These include Probability of Target Attainment (PTA), Cumulative Fraction of Response (CFR), Empiric therapy/dosing for various antibiotics and (optimal) loading dose calculations for Phenytoin.

At this time, individual accounts can not access Bayesian adaptive dosing and other advanced models, due to the additional security and compliance infrastructure, and contracting needed for the use of PHI (e.g. past doses, measured blood concentrations, genomic data).

3.
How are models validated?

The validity, reproducibility and reliability of our models are key promises of our platform. To ensure this, we perform rigorous testing at four levels to validate that our models are implemented with integrity:

  • Scientific & static code analysis: We ensure that the output values from models are exactly as defined in a peer-reviewed publication or in a pre-agreed specification for custom models. This validates that within the operating range of a model, our results will be exactly as expected from the model definition. All 3rd party libraries used to arrive at a computed outcome are also under strict source control.
  • Unit tests: this ensures that each atomic function or transformation that contributes to a model is tested every time our code changes
  • Integration tests: these ensure that functions interact reliably as they evolve, and
  • Black-box/external tests: these validate that the overall output on our website and from our APIs are as expected, independent of how the underlying functions evolve.

The integrity of models is further supported by a strict internal Secure System Development policy, which requires code reviews of all substantive changes to all our source code repositories (modeling, application, backend services, staging and even homepage updates).

4.
How many languages is Rx Studio available in?

Our application interface is currently available in English, Portuguese, Spanish, French, Hungarian and Simplified Chinese, and can be further localized for 75 countries by fine-tuning your preferred date and time format, timezone, unit of measurements (height, weight, creatinine) and default paper size for printed reports.

If you are interested in using Rx Studio in other languages and locales, or would like to help with improving the current internationalization efforts, please contact us or consult our Translation Glossary pages.

5.
What devices and operating systems are supported by Rx Studio?
Rx Studio is a cloud-based web application that can be accessed from any up-to-date web browser both from desktop and mobile devices. We also provide downloadable applications using the Progressive Web App (PWA) technology.
6.
Is Rx Studio being used in a clinical setting?
Yes, Rx Studio is currently being used to support clinical decisions in countries outside the US. Reference available upon request.
7.
How do I know if the model I selected is optimal for a patient?

Rx Studio is a Clinical Decision Support (CDS) platform. By design, our platform does not make any medical choices or decisions. Instead, given your choices and selections of models and input parameters, the platform simulates patient drug response and recommends an optimal dose to help you make an informed decision. The choice of models, regimens and target parameters are completely at the discretion of the medical professional. A trained health professional should always review the results of our platform and be the final decision maker.

While always deferring to the choices of the person running the simulation, our platform will occasionally provide warnings and guidance to mitigate the risk of anomalous data entry, improper model choice, poor model fit, (e.g. extreme PK parameters far from the related population's usual PK parameters), unexpectedly long times to reach steady-state (e.g. over 5 doses), or when the dosing recommendation output is outside known Clinical Practice Guidelines -- e.g. Rybak et al. (2020) for Vancomycin.

Integrations

1.
How long does the HIPAA BAA signing process take?
We have a standard BAA template that can be executed in 2 business days, if your organization has custom BAA requirements, the process may take longer based on mutual legal reviews.
2.
How long does it take to launch a custom model?
Depending on how well a model is documented, implementation usually takes 1-4 weeks, including validation and testing to deploy a custom model to your account. You can request a custom model here.
3.
Why are pharmacogenomic (PGx) models only available custom?
The availability of genomic and gene-expression information, and the identification of relevant transport protein markers is not currently standardized across EHR systems. To circumvent this heterogeneity, we implement custom models that are tailored to your local implementation of these markers.
4.
How long does a custom EHR integration take?
In an ideal scenario, for compatible versions of pre-integrated EHR systems, this process can be completed in a few business days. For new and complex local integrations, depending on the EHR vendor, system version, custom configurations etc. integration times may range from 2-3 weeks to several months including all administrative, technical, compliance and onboarding steps.

Company

1.
How are you funded?
We are currently self-funded (i.e. by the founders). This allows us to better control where the company invests its resources and be true to our founding mission of democratizing pharmacological models through easy access and globally inclusive pricing.
2.
How is user and patient data protected?

Please consult our Privacy Policy for details. In short: Rx Studio Inc. and our services comply with the Health Insurance Portability and Accountability Act (HIPAA). This means we maintain and follow strict Security and Privacy Rules, enforce the related controls, and audit our procedures as per HIPAA guidelines.

Some relevant controls are:

  • All personal and health information is encrypted both in transit (e.g. when sharing information with our servers for simulation models) and at rest (e.g. when data is stored in our environment for audit purposes).
  • We collect the minimal amount of patient information required for modeling.
  • We conduct a risk assessment for all potential vendors, then execute a BAA with all vendors potentially dealing with PHI.
  • Active monitoring of the cloud infrastructure and enterprise-grade application firewalls.