There are approximately 135,000 commercial clinical trial sites participating in research across Europe and over the last 12 months the number of active commercial clinical trial sites has increased by 6% according to the Medical Research Network. As a growth industry, back in 2014, the European Medicines Agency (EMA) launched the EU Clinical Trial Directive (EC) No. 2001/20/EC to support the assessment of clinical trials in the EU and provide 'the highest standards of safety for participants and increased transparency of trial information'.
Alongside this directive and the onset of the COVID-19 pandemic, the rise of solutions for telemedicine and a new way of thinking is emerging among the contract research organisations (CROs) that perform clinical trials. Taking big steps toward decentralisation using IoT. There’s a new imperative to have better, faster access to new drugs, and CROs are seeing processes that work for businesses and traditional telehealth visits can work for them as well.
The problem: CROs are not well versed in the processes, equipment and regulatory framework that are needed for decentralisation. They need a trusted third-party partner such as KORE who can handle the end-to-end IoT process as well as the challenges that inevitably arise. Some of these specific challenges include procurement of devices (such as a weight scale, a blood pressure cuff, flexible tape measure, blood draw kit, etc.), shipping them to the participants in a timely and cost-effective way, managing any issues that occur, and getting the devices returned and cleaned, or disposed of in a safe and compliant way. Once the trial is complete, all materials need to be returned, cleaned and then re-commissioned or decommissioned.
Participants also all need a tablet or handheld device to digitally capture the data. All of these items need to be purchased, kitted (loaded with properly compliant software, etc.), and then shipped to the participant. If anything breaks or there are issues, the participant needs to return equipment to be replaced or troubleshooted. Throughout the trial, data must be securely transmitted back to the CRO.
To be viable, clinical trials must also follow a stringent regulatory framework, with compliant processes for data from EMA, HIPAA, ISO and HL7. As a CRO, if you or your partner are not familiar with these regulations then your study may not deliver strong results, wasting time and money. Many companies can ship and kit, but few are FDA registered and ISO 13485 and 9001 compliant both in the U.S. and in Europe. A partner like KORE can help you manage the full spectrum of decentralised clinical trials from conception to completion, with all regulatory requirements fully covered.
KORE works with several leading CROs around the world to streamline the process of sourcing, securing, and connecting mobile devices that are used to collect patient data in clinical trials. Leveraging the most advanced IoT knowledge and experience in the industry, KORE can take the challenge of sourcing, MDM, connectivity, validation, and kitting, shipping and returns out of the equation and cut through complexity to reach your goals quickly and deliver better results for your clinical trials.