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Getting ready for Europe’s new MDR - Clinical Evaluation
The European medical regulatory landscape is undergoing its most significant overhaul in years. The eagerly-awaited Medical Device Regulation (MDR), expected to be published in Q2 2017, will bring substantial changes to the way medical device manufacturers bring their devices into the European market. At the heart of the current Medical Device Directive review lies the subject of the clinical evaluation. Our latest white paper guides you through nine important factors for the successful planning, development and maintenance of a Clinical Evaluation Report (CER).
Data protection in Clinical Trials - Is Big Brother watching?
Ensuring proper data protection in a clinical trial is a demanding & expensive process, one that may leave an organization vulnerable to data breaches. It is estimated that as many as 70% of businesses will increase spending in order to become compliant with new data protection laws. This white paper guides you through the most important actions that can be taken to understand and prepare for the new General Data Protection Regulation.
How to design your Clinical Trial - Solving the puzzle
Bringing a new medical treatment to market is a challenging process. It is estimated that clinical development programs fail four times out of five. Although a clinical trial can fail for many reasons, poor trial design is often the main cause for failure. A well-planned trial design helps mitigate failure risk and set the trial on a path to success. This paper guides you through the most important steps in successfully designing your clinical trial.
Insourcing or Outsourcing - Do the sums add up?
Insourcing or outsourcing in clinical trials is a late-breaking topic. Despite other branches of trade such as the automotive industry where large companies are experiencing a comeback of insourcing, the conduct of clinical trials are mostly outsourced to contract research organizations (CROs). This paper tackles the benefits and challenges of both approaches and sheds light on what to take into consideration when outsourcing your clinical trial to a CRO.
How data integration can transform clinical research
The pharmaceutical and medical device industries continuously look for opportunities to effectively and efficiently manage data collected in clinical trials to deliver meaningful treatments to those in need. This document guides you through the biggest trends in data integration that reduce overall trial cost and accelerate the flow of critical information to key stakeholders.
Tackling the challenges of novel cancer therapies: The clinical research perspective
Despite industry efforts, success rates in oncology have been declining ove time. More and more device-based therapies and interventions are being developed however, delivering promising results in cancer diagnostics and treatment. This white paper demonstrates that therapeutic leadership and specialized operational teams have become essential to obtain maximum efficiencies while conducting oncology clinical trials.
From idea to market: The road to a successful medical device launch
Whether you are a first-time inventor with a novel idea or a large manufacturer with a rich history in bringing medical devices to the market, the thrill of being at the forefront of an innovative concept is both exhilarating and overwhelming. This white paper guides you through the most important steps in successfully launching a medical device.
Download our corporate presentation and discover all services and interesting facts about genae.
Full service CRO
When working with us, you leverage our extensive experience in the central coordination and logistics of clinical research projects.
Clinical Regulatory and Safety services
genae provides a full range of regulatory support services for your pre- and post-marketing medical device development needs. Our experts adopt best practices while remaining on top of the ever-changing regulatory landscape.
Regulatory and Market Access services
genae's Regulatory & Safety department answers questions regarding regulatory channels to help customers achieve the most efficient path to market for their medical device.
genae runs all phases of clinical trials, from First In Human to observational registries. Our team understands your needs as well as the regulatory requirements related to the different type of trials.
genae’s global staff knows the local languages and culture, supporting your clinical trial with strong relationships in more than 350 EU and 200 US sites. We can go where the patients are, wherever you are.
Having the right approach and right resources are critical to your success. genae helps optimize your vascular trials with end-to-end services and solutions for every stage of development.
e-capture.net webinar 6 October 2016
Not all electronic data capture systems are the same. When you compare e-capture.net to other EDC platforms, the difference is clear. View this 30 min. webinar and discover all the capabilities you could gain by switching to eâÂÂcapture.net. You’ll see that our system simply offers more.
edc2go webinar 18 July 2016
The main goal of any EDC solution is to be secure, user friendly and customized to fit your specific trial. The ed2cgo platform is such an EDC tool with price transparency, is easy to use and a FREE 30day trial. View this 50 min. webinar and find out how easy it is to build an eCRF with edc2go.
core lab tracker webinar 18 November 2015
Need an efficient, secure solution to track and transfer large image data? Discover core lab tracker in our 30 min. webinar and find out how this great tool works.
genae initiated the INTEGR8 study to demonstrate the integration of a wearable device in an EDC. This publication highlights the key successes of the study: 2-way communication between wearable and EDC, as well as data correlation.