Conducting Clinical Studies in Romania and Bulgaria   Why choose Romania and Bulgaria?   Romania and Bulgaria are home to highly competitive cost solutions per patient, a unique epidemiological profile leading to a wide range of therapeutic indications, a wide availability of naïve patients, experienced researchers and highly educated health professionals working under regulatory …

The new Medical Devices Regulation 2017/745 (MDR) was supposed to take full effect in Europe by mid-2020, being a fundamental revision of existing Medical Device Directive 93/42 EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMD); following the SARS-CoV-2 outbreak in Europe, on April 23rd 2020, the EU legislator published an amendment to …

Why choose Australia?   Australia is home to some of the world’s best researchers and health professionals and boasts a world-class research infrastructure, with a long and successful history of conducting clinical studies. With one of the fastest regulatory pathways in the world, our ethnically diverse, English-speaking population means Australia is an optimal selection …

We are living in a transition period in relation to the data collection for clinical trials. The trend is that paper-based data collection is replaced more and more by Electronic Data Capture (EDC). In this article we will point out the advantages of EDC and what to take into account when selecting an EDC system. …

In recent years, Israel has morphed into an emerging and preferred destination for clinical trials, offering high-standard research and medical expertise, a diversified population and short, simple regulatory approval pathways, and relatively low administrative costs.   Big range of geographical regions and climates The country’s 22K km2 covers a broad range of geographical regions and climates, …

There will be always patients requiring innovative treatment solutions, which at times may not be able to wait for COVID-19 to subside. For those cases we would like to see clinical research continuing as best as possible at a normal pace, what is not always easy, of course. CROs are key in this process …

A Contract Research Organisation (CRO) is a company that provides support to pharmaceutical, biotechnology and medical device industries through the provision of Clinical Study services outsourced on a contract basis.   There are many advantages to untilising the services of CROs. The primary reason for outsourcing Clinical Studies is the Sponsor has limited internal resources. …

The current focus in the clinical research world is moving into technological transformation. The changes associated with this transformation have the impact on many aspects of clinical trial management, such as risk management, remote monitoring, electronic Trial Master File, electronic patient related documents, electronic patient informed consent, use of EDC software, validation of systems …

Czech Republic is one of the Central European countries with a population of 10.65 mil. inhabitants. The other Central European countries are Poland, Slovakia and Hungary (possessing together with the Czech Republic a population of more than 64 million people). Many economical, health care, and clinical research characteristics are similar in all these countries. However …

As the pandemic continues to spread all over the world, the number of investigations and studies are also growing with the aim to better understand how the COVID-19 works and to find an effective medicine or vaccine in a record time…

Spain is currently considered a country with many possibilities and suitable for quality research. There are new opportunities for research, offering significant cost savings without compromising the quality of the data…