New digital technologies on-site

The COVID19 pandemic has accelerated the rate at which various digital tools have been adopted to conduct clinical trials. Following the industry and suiting the needs we implemented new digital technologies on-site and shifted towards interacting with our patients and clients through digital channels.

Regulatory requirements of the FAST-TRACK process

Thanks to our extensive international experience and local regulatory landscape expertise we remain prepared to help you execute clinical studies with novel COVID-19 therapeutics within your even most challenging timelines. You can count on us to navigate you through the regulatory requirements of the local FAST-TRACK process to help you expedite your clinical drug development.

Investing in team’s qualifications

Continuous improvement is embedded in the culture of Biokinetica Early Phase Institute. We believe that investing in our team’s qualifications directly translates into the quality of our research and data collected in clinical trials. Our team is excited to attend a course on Pre-Clinical And Clinical Safety In Early Development Human Trials organised by the […]

3 weeks of Fast Track approval

As the Regulatory Agency, which Biokinetica Early Phase Institute is subject to remains fully mobilised to deliver fast-track assessments, it has significantly shortened the timeframes for review and registration of Clinical Trial Applications for new medicines targeting COVID-19. The RA accelerated the evaluation and approval path to the maximum of 3 weeks (or 5 weeks […]

Merry Christmas and Happy New Year!

Online SEMINAR coming up soon!

Get a unique perspective on Phase 1 Trials during the COVID-19 pandemic. Join our discussion with experts on the impact that the pandemic has had on phase 1 clinical trials and the challenges that lie ahead. Save the date and take advantage of this 4-hour meeting with industry experts to grow professionally in the area […]

Welcome Alexander Markov as our VP & CMO at Biokinetica GmbH in the USA

We are very pleased to welcome Alexander Markov, MD, PhD as our new VP and CMO at Biokinetica GmbH in the USA. Dr Alexander Markov brings more than 23 years of experience in the pharmaceutical industry to Biokinetica Early Phase Institute. He joins with a wealth of knowledge and experience in medical affairs, clinical operations, […]

Solution for dual enrolment of study subjects

At Biokinetica, we understand that the dual enrolment of study subjects may result in safety and data quality issues, and we find solutions to prevent it. We have developed a regional subjects’ database that prevents duplicated subjects in your clinical trials while screening, guaranteeing your clinical trial to meet the objectives and timelines.

PCR molecular testing to any healthy volunteer

At Biokinetica, we believe the safety measures and quality of services are of utmost importance. Therefore, we have implemented a practice of PCR molecular testing for SARS-CoV-2 to any healthy volunteer who participates in the phase 1 clinical trial at our site. Thanks to our on-site PCR testing facility, the whole process is streamlined and […]

The essence of early clinical trial success

An appropriate choice of the country, clinical site and investigators for a clinical trial is essential for the success of your early clinical development programs. Large and rapidly growing database of patients and healthy volunteers, excellent recruitment rates, highly experienced investigators, state-of-the-art Phase 1 Unit, and proven clinical quality standards are a few of the […]