AARDEX Industry Insights: Pharma Responds to FDA’s Draft DHT Guidance | EU Clinical Trials Regulation

FDA DHT Guidance | AARDEX Industry Insights

It’s hard to believe that we are already a full quarter into 2022 – and a busy one it’s been -particularly for the regulatory landscape. AARDEX® Group also announced the first in a series of virtual events, a live panel debate featuring industry adherence experts. More on this and some other key industry happenings below. 

Industry Stakeholders Respond to FDA’s Draft Guidance for the Use of DHTs in Clinical Trials

In December last year, the FDA issued new draft guidance on what kinds of devices and software may be used for remote monitoring of clinical trial participants to ensure the data is sufficient to support a product application. 

The introduction of the draft guidance was timely and while it’s been welcomed, several organizations and stakeholders from across the clinical trials continuum, including AARDEX® Group, took the FDA up on the invitation to provide feedback.

To date, over 60 comments have been submitted to the FDA, from the likes of Denali Therapeutics, Janssen, Bayer, EMD Serono, ACRO, and eClinical Forum. 

Learn more about the Industry’s response

EU Clinical Trials Regulation Creates a Framework for the Future of Research

The COVID-19 pandemic brought the benefits of remote, or Decentralized Clinical Trials (DCTs), into sharp focus, and demonstrated just what can be achieved when countries, sectors, and silos work together.

The European Union’s (EU) sweeping new clinical trials regulation, which came into force at the end of January 2022, reflects this brave new world. And the Clinical Trials Information System (CTIS), which harmonizes the assessment and supervision of clinical trials across Europe, is central to this new era.

Learn more about the new EU regulation

Webinar: Addressing Patient Adherence in the Era of Decentralized Trials

In other news, AARDEX® Group announced the first in its series of live webinars. Taking place on April 28, experts from TUFTS, THREAD, Thermo Fisher, PPD, Schreiner MediPharm, and NDA Partners LLC will take to the virtual podium to debate whether modern medication adherence tools can drive patient compliance.

As well as debating the efficacy of traditional methods for managing patient adherence, panelists will also discuss managing adherence in the era of DCTs. 

Secure your free e-pass for the event

BIOCORP® Publishes Financial Results: Reports Record Revenues & Positive Annual Net Income

BIOCORP®, a company that specializes in the design, development, and manufacturing of innovative medical devices, today announced its financial results and outlook for 2022. Among the highlights from the press release, BIOCORP® noted that not only are revenues up by 20%, but they also achieved a positive net annual income of 0.3 million Euros. Commenting on the news, Erick Dessertenne, CEO of BIOCORP stated “2021 was another year of remarkable execution of our development plan. Despite the uncertainties related to the COVID crisis and the trade-offs within the major pharmaceutical companies, BIOCORP has achieved notable success in many fields. On the commercial front, new major international diabetes and insulin players have adopted our Mallya connected device in their patient monitoring arsenal, such as Roche Diabetes Care for the French market and, even more structurally, Novo Nordisk, the world leader in the sector. These agreements have completed BIOCORP’s transformation from an R&D company to an advanced technology company”

Read the press release

Schreiner MediPharm Tackles Counterfeit Medicines with New Tamper-Proof Security Labels

Shortly after the first COVID-19 vaccine hit the market in December 2020, Interpol issued warnings of the first fakes. Counterfeiters recognized the coveted vaccine as a lucrative business opportunity.  To perfect the fraud, original containers were refilled with ineffective or harmful substitutes. In many cases, such tampering with medicines cannot be detected. 

In response, Schreiner MediPharm, a provider of high-tech labels for the healthcare industry launched a new security label that provides tamper protection for vials. The new security label prevents the unlawful reuse of original containers by means of a clear and irreversible first-opening indication. 

Read the Press Release

AARDEX® Group Ecosystem Partner, WestRock, to Exhibit at Clinical Trials Europe

Taking place in Barcelona on May 4-5, 2022, Outsourcing in Clinical Trials Europe will provide delegates with practical takeaways and solutions to their most current operational and outsourcing strategies in clinical trials. 

The 2022 program boasts multiple streams across two days, jam-packed with content covering decentralized and hybrid trials, site engagement strategies, and much more.

Planning on attending? Be sure to stop by booth 75 where WestRock will be showcasing its Clinical, Smart and Adherence focused packaging solutions.  If you haven’t registered already and work for a Pharma or Biotech organization, you can secure a complimentary pass for the event.

Secure your complimentary pass for OCT Europe

Pill Connect Ltd Publishes Usability Study Data

To support the launch of its Smart Dispenser technology, Pill Connect published the results of a usability study that was run in partnership with a major pharma company.  Their Smart Dispenser successfully demonstrated dispensing and monitoring at an individual pill level in real-time without the need for any data upload activity by the participant. Now at the design-freeze stage, the technology has been confirmed as both an intuitive and sustainable solution.

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