QILRI - Gene Therapy Clinical Research System
Qilri has been designed to support clinical research from the ground up to be the foundation for gene therapy research. The Qilri ecosystem is built on the best components available and the most proven technology available. We apply the same technology currently being employed by over 150 companies of the Fortune 500.
Qilri consists of the following components:
Trial Software:
Our 21CFRPart 11 compliant software is currently being used by companies such as Google's Verily, Roche, Zogenix and Mayo Clinic just to name a few. It is currently running over 1,100 clinical trials actively and has a history of supporting over 7,000 clinical trials world-wide. It is a complete CTMS and supports all components:
Interoperability and Recruitment:
Qilri has full interoperability with all EHR systems (including Epic and Cerner), by using the latest technology to access EMRs either via Robotic Process Automation (RPA) or in legacy systems the ability to ingest PDFs records (OCR) with over 98% accuracy. The provides the following abilities:
Using RPA, search 100,000+ medical records in a matter of 3 minutes per record. This automation allows you to search for all inclusion and exclusion criteria along with genetic markers, variants and phenotypes. Today, Kavingali has access through partnerships, to 1.5 Million active people available to match for clinical trials in the US.
If an API is used we can ingest 1 million plus records in am matter of hours with accuracy surpassing 3 standard deviations. As part of the ingestion process we employ micro services along with hashcodes for each data set. This allows the system to combine all data but also lock the data to the MRN or person permanently. This technology also allows data from all other sources to be tagged with an identifying hashcode during ingestion to immediately link it to the person/patient/participant.
Ingesting genetic sequences and exams from all source documents is easy with the ability to link, sort and parse data then add hashcode files such as BCL to FASTQ files.
Have a system that is not designed to be HIPAA compliant or 21CFRPart 11 compliant? No problem we can operate that software from within the Qilri ecosystem and provide the security and audibility to meet and exceed regulations.
This part of the Qilri ecosystem is performed by Hubcities, Inc. technology and Blue Prism (SS&C) RPA technology. Omnicare (CVS) used this technology to launch the Covid vaccine registry in less than 2 weeks.
Video: Hubcities' technology applied to infectious disease applications
Automated Analysis of Data
Qilri also offers the ability to run RPA bots across large datasets (full sequences from 1,000s of people) to identify correlations and relationships that are either identified as a search or the ability to seek correlations researchers have not identified specifically.
Qilri, also has a component that will automatically search PubMed for any new search published on specific genes or genetic markers. Thresholds can be set to alert a clinical researcher when certain parameters are met.
By applying RPA with TrialKit, bots can monitor participants at a level no human or human team could, in order to identify adverse events or serious adverse events and alert clinical researchers in a matter of minutes of being identified from either direct or passive data collection during a trial.
Post Market Surveillance and Patient Registries
Qilri supports post market surveillance and patient reported experiences seamlessly by easily transforming from a clinical trial to a post market system. It is as easy as an opt in on your e-consent and trial protocol design. Once the trial is closed an exact version of the complete trial data including audit trail is converted to your PMS or Patient Registry system. The transition is seamless and allows researchers to transition in less than a few minutes.
The software fully supports all forms of communications (text, sms, email, voice and video) for patient reported outcomes and real world experiences in a 21CFR Part 11 compliant manner. It al so supports any inventory tracking requirements for a device or disposables.
The system has the ability to geofence locations and follow data collection devices such as FitBit, Apple iWatch, glucose monitors and so on. It also offers room to grow, as more devices are added to measure lab values the technology will support that data collection in addition to your current collection.
Qilri also offers the ability to track and analyze multiple prescriptions, multiple conditions, pharmacogenetics and other variables. This offers the researcher and clinician the ability to identify the optimum prescription type and dosage for each patient/participant/person. This data can the be used with other pharmaceutical companies (in a de-identifed/patient consented manner) to collaborate and find better solutions for conditions based not only on clinical conditions but also the genetic variants of each patient/participant/person.
Startup and Return on Investment
Qilri offers a unique solution that is not offered by any other clinical trial software company. We are competitively priced compared to other CTMS systems and in many cases more cost effective.
We offer performance bonding, if needed, as well as insurance for a project. Qilri adds value by offering fast ramp up of 60 days or less to go active with a trial, to include full data integration and trial document build out. We save valuable time by offering, automation of data ingestion from EMRs (lab records, exams and sequences), automation of trial recruitment and automation of large dataset analysis; this automation can possibly cut one to two years off of your clinical trial. What is two more years of a patented treatment worth, over $1 Billion US dollars?
Qilri offers not only a good return on investment but also time.
Next Steps
To schedule a demo please reach out to us below. We can engage in non-disclosures and provide a custom solution for your therapy program.