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WEB DEMO
  • Home
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    • The Executive Team
    • Why CRFWEB?
    • Contact
      • Our locations
      • Europe – UK Office
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CRFWEB INFO SHEET

Medical Device Clinical Investigations explained

The basics: what’s the difference between a trial and an investigation?

Often, these terms are used interchangeably, but strictly speaking, “investigation” (or as is more generally used in the literature, “study”)  is the broader term. The US NIH defines a study like this:

“A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies [investigations]) and observational studies [investigations].”

So, clinical trials (or interventional studies) are a subset of clinical studies [investigations]where:

“Participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants’ behaviour, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients (or a sham device), or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants.”

In contrast, in an Observational Study [investigation]…

“…investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions (which can include medical products such as drugs or devices) or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial).”

Options and appropriate supporting technologies for Medical Device Investigations

Study/investigation design considerations

Deciding on what type of study/investigation to run is a complex matter with many interlocking factors to be taken into consideration.

  1. First and foremost, of course, the therapeutic area and specific indication that the device targets will be vital, top-level considerations. A new hip joint will naturally require a greater burden of evidence supporting safety and efficacy claims than an external knee support designed for intermittent use, for example.
  2. Almost as important is the purpose of the study/investigation. This will be a major indicator of how much data – and just as importantly, what type of data you will need to collect. For example, if you are designing a clinical trial to support an application for market access for an innovative new product in, say, risk class II, the breadth and depth of data required to adequately support claims of efficacy and safety will be significantly more challenging to acquire than that needed for a study/investigation to maintain market access under MDR PMS for an existing product operating in the same risk class with a well understood technology and safety profile.
  3. Similarly, the regulatory framework your study will be operating under will be a key issue to factor into decisions made about study/investigation design. In the EU, for example, MDR interpretation can vary from country to country so it’s vital that you have a very clear understanding of the expectations of each specific Competent Authority the trial will operate under.
  4. Finally, the depth and breadth of current scientific opinion and available data about the class of devices your device falls under will also be an important factor to take into account.

The above four factors will go a long way to determining what you will need to build into your study/investigation design to achieve compliance and specifically:

  • The number of subjects you will need to recruit to power the study statistically
  • Trial or study/investigation duration
  • The nature of and origin of data collected

Other critical study design factors to consider include:

  • Expected Geographic locations for trial sites
  • Expected number of trial or study/investigation sites
  • Logistical complexity e.g.
    • Product origin and rate of availability
    • Availability and geographic location specialist sites
    • Availability and location of critical supporting services such as Core Labs for image processing and management
  • Partners and vendors expected to support the trial or study/investigation
  • The competitive landscape – what types of study have worked for other companies with similar products on the market?

It’s important to understand that all of these factors can impact on study/investigation design – for ALL study types. And influence the choice of technologies to support study conduct and any needs to integrate technologies to streamline study/investigation conduct, lower risk and improve data quality.

If you would like to read more about study/investigation planning for PMCF under MDR, click here

How we can help you

CRFWEB is a full-service EDC system optimized for medical devices. CRFWEB will support your journey to compliance providing a single, integrated platform for:

  • Clinical trial design
  • Data capture by site or subject
  • Trial process management and troubleshooting
  • Data management, analysis and reporting

The CRFWEB software suite delivers all the key functionality you will need to ensure an MDR-compliant clinical trial in an agile, simple-to-use package optimised for the needs of medical devices at a fraction of the cost of the industry big names.

Contact us today to book your demo

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What our clients say

Maria Galligan, PMD Solutions

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

Dr Salvi, CRF Health, India

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

Nigel McLean, Cytosystems, UK

" CRFWEB eCRF, plus their helpful and accommodating staff, helped us quickly set up and personalize, with quick turn-around times of modifications, exactly what we, the clinical staff, and statistical consultants demanded, all at an affordable price "

Kelly Seamans, Atlantia

" The Clindox (CRFWEB) team are dedicated and enthusiastic about accommodating the unique requirements of each individual study and are great value for money."

Dr Satish Kumar, G7 Synergon
"Our international CRO business has utilized Clindox's integrated randomization module and Kit Management. The functionality provides everything we need, and having key trial components integrated into one system is a huge advantage to us in terms of trial efficiencies. Having both randomization and kit management capabilities, aligned with the EDC really simplifies the whole process and significantly reduces the time and effort required to manage our studies and keep control of our processes and inventory. "

Next Steps

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