Solving Mysteries with Genetics

News

27 Feb 2020

Solving Mysteries with Genetics

Launched in the early 1990s and completed in 2001, the Human Genome Project  provided the basis for a wide range of studies of human biology and medicine. In the years that followed, advances in next-generation sequencing (NGS), coupled with data from the Human Genome Project, led to a better understanding on how DNA replication processes vary from person to person, aiding physicians […]

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Novel Approach: Using Viruses to Attack Bacteria

News

18 Dec 2019

Novel Approach: Using Viruses to Attack Bacteria

Alexander Fleming’s discovery of penicillin in the late 1920s revolutionized the treatment of infectious diseases. But the increasing prevalence of antibiotic resistance and the emergence of multidrug-resistant ‘superbugs’ shows the limitations of what was once considered a wonder drug. In his 2018 TED talk Alexander Belcredi, MBA, the Chief Executive Officer of PhagoMed Biopharma, a German biotechnology company developing phage-based […]

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The Increasing Value to Standardizing Data

News

8 Dec 2019

The Increasing Value to Standardizing Data

At EvidentIQ, we see the digital revolution’s potential to radically improve global health care, and we are prepared for it.   But this transformational shift also brings a sizable challenge: how to collect, store, and manage the proliferation of data created by digital tracking and measurement devices and derived from a growing number and type of […]

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The WHO Global Strategy on Digital Health: What You Need to Know

News

3 Dec 2019

The WHO Global Strategy on Digital Health: What You Need to Know

In April 2019 The World Health Organization (WHO) released a draft of a digital health strategy. Known as the WHO Global Strategy on Digital Health 2020-2024 (or, for short, The Strategy), its vision is to, “improve health for everyone, everywhere by accelerating the adoption of appropriate digital health”. As arguably the most influential organization that moderates […]

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Reducing the Effort of Building an eCRF

News

20 Aug 2019

Reducing the Effort of Building an eCRF

Data is the linchpin for the billions of dollars dedicated to medical studies—and the eCRF is the main collection vehicle for that data. A high-quality eCRF design is therefore as important as the data itself and requires extensive planning and attention to detail. The ideal features of an eCRF, like all good design, should facilitate […]

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Applications and Value of RWD and RWE

News

8 Aug 2019

Applications and Value of RWD and RWE

In continuation from our previous blog on what real-world data (RWD) and real-world evidence (RWE) are and where sources are from, in this post, we will be illustrating the value of RWD and RWE, as well as discussing examples of their application. Why Use RWD and RWE The gold-standard randomized clinical trial provides a highly narrow snapshot of the efficacy and […]

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Bringing Clinical Trial Wearable Technology Data into EDC Systems: Why It Matters

News

17 Jul 2019

Bringing Clinical Trial Wearable Technology Data into EDC Systems: Why It Matters

I recently spoke with Emily Mitchell, Senior Director, a member in the Biometrics Portfolio Operations Department at PRA Health Sciences, which encompasses all of the company’s data management, biostatistics and programming services. The conversation was about her experience with wearables as part of PRA’s Real World Solutions Department which focuses on peri-and post-approval studies. Emily headed […]

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HIPAA Compliance Requirements: Keeping Clinical Trial Data Private

News

8 Jul 2019

HIPAA Compliance Requirements: Keeping Clinical Trial Data Private

The Health Insurance Portability and Accountability Act (HIPAA) was introduced in 1996 in the US to establish national standards that protect patient health information (PHI), as well as set limits on the conditions of its use. PHI includes details such as the individual’s past, present, or future physical or mental health or condition; the provision of […]

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Beyond the Clinical Trial: Real World Data and Real World Evidence

News

2 Jul 2019

Beyond the Clinical Trial: Real World Data and Real World Evidence

At EvidentIQ, we are all about data, and it is our mission to make it as easy as possible to collect robust, high-quality data during clinical trials, but also in registries and real-world/late phase studies. We recognize the growing role that real-world data (RWD) and real-world evidence (RWE) are playing in decision-making processes during the […]

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The Converging Clinical Research Environments of Drug and Medical Device Trials

News

24 Jun 2019

The Converging Clinical Research Environments of Drug and Medical Device Trials

Medical device development is following a similar evolution to drug development in terms of regulation. This is primarily to ensure that medical devices meet the same robust safety and efficacy requirements as drugs. However, we are also seeing convergence between the regulation of drugs, medical devices, cosmetics and nutritional products as international regulators anticipate a […]

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Discover the Business Value in Selecting One Single Electronic Data Capture Solution for All Your Clinical Trials

News

10 Jun 2019

Discover the Business Value in Selecting One Single Electronic Data Capture Solution for All Your Clinical Trials

In a recent LinkedIn post, we mentioned a discussion with a mid-pharma/biotech leader who was not interested in partnering with an EDC solution vendor. This person said that they completely delegate the software selection task to their CRO partners, which is rather common in our industry. In this article, we will look at this from […]

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A Personal Summary of the CDISC European Interchange Conference in Amsterdam

News

3 Jun 2019

A Personal Summary of the CDISC European Interchange Conference in Amsterdam

The CDISC European Interchange Conference, May 8th and 9th, 2019 in Amsterdam focused on the advancement of CDISC standards towards machine-readable metadata and compatibility with other standards. I was very happy to learn that CDISC will soon be publishing a mapping table between its LAB test codes and LOINC (Logical Observation Identifiers Names and Codes), a well-known industry standard. The document is […]

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