Good Clinical Practice (GCP) site audits are not conducted for all clinical studies, yet they are a key quality assurance function, providing a valuable comprehensive overview of a clinical study – not only to determine if the objectives of International Conference on Harmonization (ICH) GCP are being met and the required standards adhered …
The African continent has attracted the global pharmaceutical industry’s attention due to its unique profile: low access to quality healthcare, epidemiological transition, fast-growing population, a rising middle class, and rapid economic growth. And the expanding middle class – with its ‘Westernized’ lifestyle – has a concomitant effect: an increase in non-communicable diseases (NCDs), …
PROMETRIKA’s portfolio of services includes extensive work in New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs). In the company’s 16 year history, PROMETRIKA team members have collaborated on 19 NDAs and MAAs. Our data managers, statistical programmers, biostatisticians, and medical writers have designed, implemented, and reported on the clinical submission data in indications …
Every clinical study is led by a principal investigator, but real decision maker is the Sponsor. According to the definition the Good Clinical Practices’ guidelines, the Sponsor is responsible for the initiation, management and/or financing of a clinical trial Below we describe 5 main aspects Sponsors should be aware of when running a clinical study: …
Did you know that Latin America is considered one of the best areas to perform a Clinical Trial, mainly because of the huge range of possibilities offered for clinical research? Starting by its high recruitment and retention rates (LATAM boasts a surprisingly interesting cost/efficiency ratio) along with the advanced information technology, Latin America counts with …
Romania and Bulgaria are a great and affordable environment to perform clinical studies in Europe. Their regulatory environment, together with the qualified doctors and their outstanding recruitment performance are some of the reasons we are analyzing in this post.
Clinical testing conventions are a huge opportunity to meet new colleagues, update our partners list and have an interesting time learning from the industry we love.
Spain is currently participating in approximately 18% of all the clinical trials conducted in Europe, and due to the legislation we are analyzing in this post, it will certainly increase its competitive position.
With a population of over 64 million people, Central Europe has become an interesting target for medical companies looking to test their products: Discover what to expect if you are considering to run a clinical trial there.
Our aim is to help companies who are conducting multinational clinical testing, by offering the knowledge of local experts and adding value through the entire process.