Implementing Technology for New EU Requirements on Medical Devices

EUIn late September, the European Union approved legislation for a new approval system of high tech medical devices that mirror the approval process of the FDA. ARITHMOS gives a brief outline of the new proposed amendments and why Sponsors should consider implementing technology solutions in order to conduct more efficient and affordable clinical trials. 

The current medical device approval process in the EU is guided mostly by national law. A conformity assessment is performed by a notified body and the device obtains a CE marking meaning it can be sold in the European Economic Area.

The new legislation would eliminate the equivalence principle commonly used for market approval and require more sophisticated clinical trials. This means trial costs are going to increase as there will be a need to collect additional clinical data to demonstrate the efficacy and safety of a medical device. In an effort to guarantee patient safety, the EU is proposing more follow up during post-market including more post-market studies. Companies will need to prepare data in a traceable and readily available way. 

How can Sponsors use technology to counter these changes?

One characteristic of medical device trials is that there is a lot of variance and therefore protocol and study design are crucial. Device studies have many factors to consider such as small populations, site differences and unique study endpoints. Incorporating EDC solutions into medical device trials can be very beneficial. The availability of integrated data can enhance the overall development process through greater efficiency and effective decision-making. 

Immediate Feedback: Sponsors can resolve discrepancies faster and reduce time and costs with immediate feedback from patients. Data can be transferred in real time during the study and query management is accelerated. 

More Accessible Trial Information: An EDC solution can organize multi-language, global study data into a single database. This is especially beneficial to statisticians who need up-to-date study metrics, especially if they are applying an adaptive trial design method to the trial. 

Higher Data Quality: EDC improves the quality of data through automated edit and discrepancy checks, faster data cleaning, audit trails and compliance with GCP and regulatory guidelines.

 

ARITHMOS has a variety of EDC solutions to fit any study budget or requirements including smaller medical device studies which require a reliable, yet cost-effective solution. Contact us to discuss your EDC options.

12320709-medical-instruments-for-ent-doctor-on-whiteSponsors should also consider pharmacovigilance applications for the analysis of safety data. ARITHMOS offers two customized reporting solutions to automate signal detection and make safety data available in real-time. 

In addition to medical device legislation changes, Sponsors should also be aware of changing pharmacovigilance legislation in the EU. The Good Vigilance Practice (GVP) regulations went into effect in 2012, and more recently, the EMA has released guidelines for complying with ICH E2B (R3) which regulates electronic transmission of individual case safety reports. 

Pharmacovigilance Day – 12 November 2013 in Milan

For more information on pharmacovigilance technology solutions and EU regulations (or even questions on medical device trials), ARITHMOS invites you to participate in Pharmacovigilance Day taking place in Milan on 12th of November. This is a free seminar being conducted by ARITHMOS and Oracle Corporation on technology solutions to face the challenges of pharmacovigilance. More information is available here.

Clinical Trial Technology Guide for Biotechs

3-3-2-Cancer-Research-ABiotech companies often face challenges in product development – from finding appropriate funding to managing clinical data. Solutions like centralizing data and incorporating technology can reduce costs and improve efficiency. ARITHMOS discusses technology options for biotech companies conducting trials and preparing products for due diligence and licensing.

The European biotech picture looked bleak for a few years with a drop in funding and fewer products on the market and fewer biotech companies in the market. For example, the number of biotech companies in the UK leveled off, while products in the Phase III pipeline increased. Germany saw an increase in the number of biotechs and stagnation in the number of products on the market. In the past year, France’s biotech industry saw a funding boom and new products are entering the development pipeline.

These biotech companies increasingly need support in terms of funding and managing product development as it continues into late phases. Selecting the right technology package can be an ideal strategy.

Technology services, including EDC and ePRO solutions, pharmacovigilance applications, centralized storage and data visualization, can become part of a centralized outsourcing strategy. Using the same ePRO/EDC/IWRS reduces training and HelpDesk costs and allows for easy data integration. There would be only one set up fee for safety databases and volume discounts are applied.

How can biotech companies justify incorporating technology into their clinical trial strategy?

Centralizing data storage using a single database means there is only one database to maintain and one repository to back up. Security procedures can easily be put into place and data confidentiality is ensured, and data is easily transferable to the Sponsor via web portal containing metrics and reports. Setting up global libraries, programming macros and validation checks incur a one-time fee only. In terms of EDC, biotechs can benefit from volume discounts on licensing fees as well as pharmacovigilance database fees.

EDC Solutions: By adopting the same ePRO/EDC technology, biotechs can reduce training time and HelpDesk costs are minimized. In addition to immediate feedback and accessible trial information, EDC solutions can also increase data quality which is important for biotechs who are preparing for due diligence. EDC improves data quality by storing data in an encrypted mode, cleaning data faster with Alert and Query Manager, automated edit checks and discrepancy checks, audit trails and compliance with GCP and regulatory guidelines.

ARITHMOS EDC Solution for Biotechs: ARITHMOS has developed a simple and inexpensive EDC technology platform to effectively manage clinical trials and collect patient data. Symphony EDC is a reliable, cost-effective solution where a simple interface is needed.  It is a Software as a Service (SaaS) electronic data capture solution which allows users to only pay for the functionalities needed.

For more information on the appropriate technology solutions for your biotech, contact us at info@arithmostech.com

CDV1ARITHMOS is also hosting a free seminar on Wednesday, 13th of November at the University of Milan-Bicocca in Milan on Symphony and EDC solutions to meet any budget and study requirements. During this seminar, experts will demonstrate how Symphony can increase efficiency, produce higher quality data with real-time results and improve timelines all while staying within budget.