The eSource Platform for Early Phase trials and Site Automation

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 Baxter (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.

In conclusion, ClinSpark is very much a strategic investment for a site or early phase CRO, in order to adopt eSource as an operating platform for all their trials, and is not necessarily intended as a tactical solution to be used for individual trials.

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?

What is ClinSpark?

Learn in one minute what ClinSpark is and how it can help solve your clinical research challenges.

Connect, Collaborate, Accelerate

ClinSpark is built from the ground up on the most modern technology standards.

Connect

However complex your research needs, all systems and devices can connect into ClinSpark, so you can access all study data in one place.

• In­-depth cardiological analysis of ECG and telemetry data

• Adverse Events monitoring and follow­-up

• Automatic receipt of lab ­results for real­time access to safety data

Collaborate

Because everyone is looking at the same data in real ­time, teams can work more closely together and get to better decisions faster.

• Share graphs using your preferred data visualisation tool

• Create reports using data exports and your preferred tools to make safety review meetings more productive

• Clinic and data management together supporting data standards

Accelerate

ClinSpark is designed with Ease of Use in mind. Your staff will find it to work better and faster than conventional methodologies.

• No transcriptions - so fewer errors

• Barcode­ navigation - no need to touch keyboard

• Essential study progress reports with one click of a button

ClinSpark Features

A unique set of features make ClinSpark the ideal eSource platform for all phases of clinical research.

Lab Interface

Automatic generation of safety-lab orders, capture and batch review of lab-results. Works with your safety lab of choice.

Device Connectivity

Connects to common medical devices used in your clinic and downloads data automatically, eliminating transcriptions. If your equipment is not currently integrated, the chances are we can connect it.

Recruitment Database

Select subjects based on extensive demographic and medical data and communicate with them directly via phone, email or text-messaging.

ECG Review

Extensive connectivity to ECG and telemetry systems for in depth analysis of ECG’s, providing core-lab features at your fingertips.

CDISC Certified

Built from the ground up on CDISC standards. It's the first Phase I eSource platform to be CDISC ODM certified.

Data Analytics

A ‘read-replica’ database allows you to connect to real-time data using your favourite data analytics tool, such as Tableau or Spotfire.

Who benefits from using ClinSpark?

Everybody working on a clinical trial will benefit from using ClinSpark. The Sponsor will have in-depth 24/7 insight into study status. The Scientist will have extensive tools to review study results in real time. The Data Manager will enjoy very clean data to work with. But the biggest benefits occur in the clinic. Learn from these professionals how ClinSpark helps them in their daily tasks.

Easy to use User Interface

Designed in todays ‘mobile first’ tradition, navigating ClinSpark immediately feels intuitive and familiar.

Workflow

ClinSpark supports the whole workflow, from recruitment, through study conduct, all the way to database lock

Data Collection

What does data collection without transcription mean and how can the built-in workflow support help you to prevent timing errors and missed assessments, while navigating by scanning barcodes?

Dosing

See how a cohort can be dosed with a defined stagger and subsequent assessments being timed throughout the study. Learn how the countdown timer prevents missed events and barcode scanning as well as built-in checks prevent errors.

ClinSpark connects to many medical devices, instruments and systems.

Lab Interface

What is the lab interface and how does it help you to automatically create lab orders and collect data from the safety lab(s) of your choice for easy review and sign-off?

Safety Lab

See how to setup custom panels of safety lab tests and send the lab orders from within ClinSpark. Learn how investigators get real-time access to results, get alerted to out-of range values, and can review and sign-off.

ECG

See how ClinSpark connects to your ECG-device or telemetry system and collects data automatically. Learn how to review and analyse ECGs using class leading software as used by most ECG Core-labs, straight from within ClinSpark.

Software as a Service

ClinSpark is fully cloud-based and is offered exclusively as a SaaS solution with a subscription-based pricing model.
This has some great advantages for you:

Low Investment

Our web-based deployment means fast implementation timelines and minimal upfront investment.

Pay per Use

No upfront license fees, just a monthly fee that is largely based on usage, turning fixed cost into flexible costs.

Monthly Cancellation

We are so convinced about our offering that we provide ClinSpark without a long-term contract. You can cancel anytime with a month's notice.

Foundry Health, an IQVIA business

Foundry Health, an IQVIA business, is a digital health company that seeks to empower health professionals by building software tools that put the patient back at the center of each encounter.

We believe in challenging the status quo by creating strategic solutions that reflect researcher needs, industry trends and “out of the box” thinking. We do this to increase subject empathy and compassion while speeding up the delivery of tomorrow’s drugs for today’s illnesses.

We work with a team of enthusiastic professionals with the sole focus to make ClinSpark the new standard for eSource platforms in clinical research.

We are proud to have a very enthusiastic and thriving client base. The number of clients that are using ClinSpark is rapidly growing. Our clients are based globally and include both commercial CRO and Large Pharma organizations.

We believe that the strength of our solution is for a large part determined by its interaction with other systems. Therefore we are very pleased to have strong connections with leading partners in the industry.