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The eSource Platform for Early Phase trials and Site Automation
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Introduction
ClinSpark is the only CDISC ODM certified eSource and automation platform for early phase clinical trials. We use AWS' class-leading hosting services in either North American or EU (and in future Asian) regions.
We supply ClinSpark to a number of CROs and Pharmaceutical Company Phase I units in the US and Europe.
ClinSpark is different to EDC systems, where the source data is captured on paper and then transcribed to an eCRF. EDC is usually deployed by the sponsor or CRO and used on demand, one study at a time. However, with eSource, it is the sites themselves that adopt ClinSpark as their platform for the conduct of all their clinical trials, and as a way to increase compliance, reduce errors and increase efficiency, as well as delivering SDTM-like exports in SAS® transport file format. In addition, the sites provide controlled and secure access to the source data in ClinSpark, to the trial sponsor and/or trial monitors. Importantly, the data is owned and retained by the investigational site.
ClinSpark maintains a database of your trial volunteers and was designed to be HIPAA compliant. It is used to support the identification, selection and enrolment of eligible participants and includes optional integrations with Twilio and SendGrid for voice, messaging and email communications, before, during and after a trial is completed. Through APIs, we can import details of potential participants from your volunteer recruitment and marketing website.
ClinSpark leverages the use of barcodes for medication containers, sample containers and for participants (by means of wristbands) and even for staff if required, to support fast data collection, error prevention and automation of workflows. They are used heavily for sample processing workflows (from 'vein to freezer', and even on to packaging and shipment).
We take advantage of the configuration flexibility within ClinSpark to create HL7-based workflows for sending orders to, and receiving results back, from your in-house or preferred external safety labs. Physicians can review results, determine clinical significance, and order repeats where necessary. Results are signed electronically in compliance with 21CFR11.
We currently support a range of VS, ECG and other medical device and instruments integrations from several vendors including HillRom, Mortara, WelchAllyn, GE Medical, seca and Konica Minolta. These integrations eliminate demographic and transcription errors and store the captured source data directly in the database including ECG XML and PDFs of waveforms. ClinSpark includes an optional integration with CalECG by AMPS LLC that allows on-screen measurement of ECG signals that would normally be the domain of cardiac core labs. We have recently added integrations with additional devices including for the measurement of spirometry and blood glucose initially for later phase trials.
ClinSpark includes automated medical coding tools, so when used together with SAS®, it provides the complete toolkit to:
design and build trials
select and recruit qualified trial participants from your database
schedule and perform real-time data collection at the bedside and in the sample processing lab
provide direct access for monitors and data managers to the source data so that it can be queried and cleaned
perform medical coding
export data in XLS, CSV, XML and XPT formats
lock trial datasets and prepare submission-ready hyperlinked PDF CRFs
prepare SDTMs and ADaMs
Our customers found that using ClinSpark for the conduct of clinical trials during the COVID19 public health emergency to be of great value, as many sponsor oversight and monitoring tasks could be conducted remotely.
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Data vs Paper
All Phase I clinics and later phase research teams face similar challenges: Lots of data, systems, assessments, changes, paper and spreadsheets. So how to keep focused on volunteer safety and study results?
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