Medical Devices

Here at Clinical Accelerator we conduct clinical investigations of medical devices in all main therapeutic areas, including the cardiovascular, neurological, orthopedic, dermatology and cosmetics fields, for international medical technology companies.

In our experience, we’ve recognized that the majority of companies in the medical technology industry are small- and medium-sized enterprises (SMEs) and we’ve come to understand a common significant challenge for these companies: meeting the ever-increasing cost of medical device trials.

Keeping this in mind, Clinical Accelerator has developed a model of operation built around the needs of SME medtech companies. We allow our clients to obtain valuable early feasibility human data with minimal capital needs and help secure additional funding. We accelerate their pivotal clinical studies but also reduce the cost of them. Ultimately, we bring their much-needed innovative medical devices to the market fast.

Full regulatory compliance

We run both early feasibility human studies, larger pivotal studies evaluating the safety and performance of medical devices, and post-marketing studies. The data which we produce fully meets the ISO 14155:2011 and the new 21 CFR 812.28 FDA requirements and can be used to support an IDE or a device marketing application or submission through any applicable regulatory pathway: 510(k) or de novo classification, PMA or HDE.

We are also taking into account the new Medical Device Regulation (MDR) which should become effective in the European Union as of 26 May 2020. MDR will impose new, much more stringent requirements for CE Marking of new and existing medical devices, particularly in the form of mandatory clinical data. We are prepared for this change and are ready to implement clinical studies that are in full compliance with the new EU regulation.

Where we run our studies

Our geographic coverage includes many locations in Central and Eastern Europe (CEE) well suited for medical device trials with a streamlined and pragmatic system of study approvals and modest cost of clinical investigations. Our regulatory managers provide necessary guidance and engage in effective interaction with the local authorities to ensure time-efficient and painless approval process. Our multilingual staff ensure seamless and effective communication between all the parties involved in clinical investigations through the whole life cycle of our projects.

We look at each investigational medical device individually and select best suited locations and sites in our vast region of operation depending on the type and class of device, its stage of development and the therapeutic area.

Clinical Accelerator works in partnership with a network of highly competent investigators and many excellent regional investigative sites (including FDA-inspected sites) experienced in medical device investigations. Our partner sites have excellent access to patients and are proven efficient recruiters into clinical trials in their therapeutic areas. They deliver quality clinical data on economical budgets.

Clinical CRO services and patient enrolment support

Clinical Accelerator offers our medtech clients a full spectrum of clinical trial services for medical device investigations. In addition, we also offer regulatory support in dealing with international regulators and offer complementary expertise to our clients in any field they may require.

Within our organization we have dedicated personnel entirely focused on patient enrolment and retention. Our patient enrolment managers participate in study feasibility assessments, analyze patients pathways and identify recruitment challenges. Together with our investigators, they design and implement effective, regionally adapted patient enrolment and retention strategies. The end result is that we deliver fast and efficient patient recruitment into our studies with low drop-out rates and commit to achieving patient enrolment targets for our clients within fixed short timelines.

 

We look forward to accelerating the clinical development program of your medical device!