Clindox – Proven Specialists in eClinical Solutions

The Clindox team's focus and experience in medical device investigations means our eClinical platform provides all the tools you're likely to need to meet your regulatory requirements. Clindox will also provide you with the opportunity to discover new scientific, technical and operational insights derived from your data.

The Medical Device eClinical People

Compliance and regulatory requirements

FDA (CDRH) 21CFR 807 and 814, GDPR, HIPAA, MEDDEV, MDR and the transition to IVDR.

Integrated Features

EDC via browser or app, researcher or subject-led. Medical coding (MedDRA) – SDV – SDTM – Integrated Randomization – Trial Supply Management: IP/Kit Management.

Decentralized Trials

Clindox now features a fully integrated ePRO module and a complementary eDiary module for decentralised and/or hybrid trials and post-market studies. ePRO & eDiary can be accessed via a browser or the Clindox App.

Device study specific features

Device logs: AE, ADE, SAE, SADE, USADE, randomization for sham controlled studies.

Understanding the demands of Medical Device Data Capture and Management

Clindox is being used by a variety of clients in a number of countries for their medical device EDC requirements. We understand the needs of medical device investigations. We have a template library of relevant medical device adverse event/effect logs – AE, SAE, ADE, SADE, USADE. We can perform sham-controlled randomized trials with our randomization module.

We are also well positioned for the move towards decentralised and hybrid trials with a number of Direct Data Capture and subject-led data capture options through the Clindox App.

What study options are available for medical devices?

What are the design considerations and supporting technologies?

Making sense of Medical Device Compliance in a complex global market

MDR: are you in shape to achieve regulatory compliance?

We all understand the transition to European MDR regulations is increasing the burden of compliance for the medical device industry in both gaining and retaining that all-important CE-Mark. Not only will many companies no longer be able to base their initial submissions on equivalence, MDR will increase the requirement for Post-Market Clinical Follow-up for most device classes.

An eClinical platform built to exacting standards can ensure your pre and post market investigations are delivered smoothly and efficiently to meet your regulatory requirements.

Understanding the impact of MDR on PMS & PMCF

Since the Date of Application (DoA), 26 May 2021, for MDR, manufacturers have a statutory requirement to collect post market clinical data as a continuous process over the device lifetime. The aims of Post Market Surveillance (PMS) under MDR are:

  • Confirming the safety and performance throughout the expected lifetime of the device
  • Ensuring the continued acceptability of identified risks
  • Detecting emerging risks based on factual evidence

The rationale for PMS under MDR

PMS is a cornerstone of MDR. With the explosion in the number of medical devices reaching the market since the turn of the century, it had become increasingly clear that existing compliance processes were no longer fit for purpose and that devices were achieving market entry without adequate clinical data supporting claims for safety – or efficacy.

Paper, spreadsheets, legacy databases or eCRF?

If you have current data in paper, spreadsheet format or legacy databases, we can help. With Clindox we can develop an eCRF from that and import data, as appropriate allowing you to benefit from the efficiencies offered by our SaaS solution.

Deploy Clindox for these study types:

  • Pilot or Feasibility
  • Post-Market Safety
  • First-in-Human
  • Registry
  • Pivotal
  • Investigator Initiated
  • PMCF

"Clindox is a critical part of your strategy to get your products to market and keeping them compliant post-market."

What Our Clients Say

"The Clindox team have been an incredible support and are always available to help in any way they can."

MARIA GALLIGAN
PMD SOLUTIONS

"The time and cost saving is really significant. We're very happy with the performance of Clindox and I wouldn't hesitate to recommend it."

DR SALVI
CRF HEALTH, INDIA

"Clindox eCRF, plus their helpful and accommodating staff, helped us quickly set up and personalize exactly what we and the clinical staff demanded."

NIGEL MCLEAN
CYTOSYSTEMS, UK

"The Clindox team are dedicated and enthusiastic about accommodating the unique requirements of each individual study."

KELLY SEAMANS
ATLANTIA

Next Steps

For system overview, click here. Seeing is believing. Book a consultation now.