Due to our high commitment to clinical research we provide people even with free advice with regards to minor GCP related topics on a daily basis, visit therefore GCP mindset youtube channel.

What everybody should know about Clinical Trials! Without clinical trials, we wouldn’t have any vaccines, treatments for cancer, heart disease, diabetes and many others. What should everybody know about Clinical Trials? How are pharmaceuticals and medical devices developed? This is our new video of our series about the basics of clinical trials to give you some answers. Part 24 – Equivalence in Clinical Evaluations is presented by our expert Carol Lazovic.

What everybody should know about Clinical Trials! Without clinical trials, we wouldn’t have any vaccines, treatments for cancer, heart disease, diabetes and many others. What should everybody know about Clinical Trials? How are pharmaceuticals and medical devices developed? This is our new video of our series about the basics of clinical trials to give you some answers. Part 23 – Jobs in Clinical Trials: Clinical Project Manager is presented by our expert Carol Lazovic.
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What kind of variable are we dealing with? Is it measurable or countable and therefore of quantitative nature? Or is the data given in classes, indicating qualitative variables? In our new video we will explain with practical examples for clinical studies what the differences are, and how to clearly distinguish these two data types.

German Movies (Engl. subtitles):



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Neben der neuen europäischen MDR gibt es auch andere wichtige Änderungen z.B. im Einreichungsverfahren durch das neue deutsche Medizinproduktegesetz. Welche Auswirkungen gibt es noch auf klinische Studien, auf was sollte man in den eigenen Studien achten oder bedenken?

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Die neue Medizinprodukte Verordnung der EU ist da – was bedeutet das für die Entwicklung neuer Medizinprodukte? Unterschiede und Überschneidungen zu der Medikamentenentwicklung?

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Die neue MDR der EU im Detail – was ist neu?

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Was genau ist Centralised Monitoring und wo liegen die Vorteile für die Klinische Forschung?

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Was ist Product Safety und wie gehen wir dieses Thema am besten an?

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Die Rolle des Zentrallabors ist besonders für multizentrische Studien von großer Bedeutung – erfahren Sie in unserem neuesten Interview mehr darüber!

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GCP Mindset: Worüber wollen wir sprechen?

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Prüfärzte müssen für die Teilnahme an klinischen Prüfungen entsprechende Fortbildungen mitbringen. Welche genau und was es zu beachten gilt in unerem neuen Video.

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Outsourcing ist ein wichtiges Thema in der klinischen Forschung, aber was ist effektives Outsourcing?

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Was bedeutet das FSP Modell und wie funktioniert es? What does FSP mean and how does it work?

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Was hat sich im Bereich Clinical Monitoring in den letzten Jahren geändert?

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Klinische Prüfung in der Verkehrsmedizin – spannende Einblicke in eine unbekannte Nische!

What everybody should know about Clinical Trials

What everybody should know about Clinical Trials! – Part 1
Without clinical trials, we wouldn’t have any vaccines, treatments for cancer, heart disease, diabetes and many others. What should everybody know about Clinical Trials? How are pharmaceuticals and medical devices developed? This is our first Video of our new series about the basics of clinical trials to give you some answers. Presentend by our experts Kelsey Crossman and Carol Lazovic.

Part 2
Medical Device Legislation is presented by our expert Kelsey Crossman.
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Part 3
What is a Medical Device is presented by our expert Kelsey Crossman.
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Part 4
What is a Medical Device is presented by our expert Kelsey Crossman.
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Part 5
Phase 2 Trials is presented by our expert Carol Lazovic.
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Part 6
Phase 3 Trials is presented by our expert Carol Lazovic.
Part 7
Phase 4 Trials is presented by our expert Carol Lazovic.
Part 8
The Declaration of Helsinki is presented by our expert Carol Lazovic.
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Part 9
Informed Consent is presented by our expert Carol Lazovic.
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Welcome to the year 2021! The year of Science and much more! But before we tell you all about Clinical research, here’s some trivia time! Pharmaceutical research continues to create a difference in drugs and medical devices development, science and Technology is taking as all at a warp speed as we all strive to find new therapies and treatments across the globe! There are several weird and wonderful pharmaceutical facts, some still waiting to be discovered but while we keep searching, here are some of our favourite ones so far! We’re curious to read some funny ones you may think of!
Here comes our second video with some other interesting pharma facts!
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Part 10
Adverse Event is presented by our expert Kelsey Crossman.
Part 11
Serious Adverse Event is presented by our expert Kelsey Crossman.
Part 12
What are Vaccines is presented by our expert Kelsey Crossman.
Part 13
Adverse Drug Reaction is presented by our expert Kelsey Crossman.
Part 14
SUSAR Suspected Unexpected Serious Adverse Reaction is presented by our expert Kelsey Crossman.
Part 15
Vaccines Types is presented by our expert Kelsey Crossman.
Part 16
Jobs in Clinical Trials: CRA – Clinical Research Associate is presented by our expert Kelsey Crossman.
Part 17
Jobs in Clinical Trials: – Study Nurse is presented by our expert Carol Lazovic.
Part 18
I had Covid-19 is presented by our expert Carol Lazovic.
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Part 19
Jobs in Clinical Trials: Online Training Manager is presented by our expert Kelsey Crossman.
Part 20
Jobs in Clinical Trials: Medical Writer is presented by our expert Carol Lazovic.
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Part 21
Jobs in Clinical Trials: Trial Master File Manager is presented by our expert Kelsey Crossman.
Part 22
Essential Documents is presented by our expert Kelsey Crossman.
Part 23
Jobs in Clinical Trials: Clinical Project Manager is presented by our expert Carol Lazovic.

Part 24
Equivalence in Clinical Evaluations is presented by our expert Carol Lazovic.

Why we do things differently

Why do so many organization still work with paper TMFs? What are the benefits of replacing paper trial master file by an electronic TMF (eTMF) in Clinical Trials? Is working with paper based TMFs in clinical studies obsolete? Or does it even have negative impact on your study documentation. Find out what makes eTMFs so much better than traditional paper TMFs in our video!
Since 1997 onsite Monitoring is an important part of the conduct of clinical study. However, using onsite monitoring as the only method of quality control is neither intelligent nor cost effective. The implementation of statistical monitoring processes to target onsite monitoring is a scientific method which can improve the quality of study data significantly while saving costs.
As Patient reported outcomes become more and more popular in generating data directly from patients in form of Quality of life Questionnaires or diaries in which patients can report side effects or adverse events on their own, such useful source data require to be consistent, of high quality and integrity. Find out why patient reported outcomes as important sources of information should no longer be recorded on paper.
What are the benefits of replacing paper investigators site files by an electronic ISF (eISF) in Clinical Trials? Unlike 10-20 years ago, working with paper based ISFs in clinical studies is obsolete. It may even have a negative impact on the risk benefit profile of a study. Why do we put CRAs in conflict between inspection-ready paperwork and patient safety? Safety first please! Find out about all benefits of the transition to eISFs in this short video.

FDA:” During the past two decades, the number and complexity of clinical trials have grown dramatically. These changes create new challenges to clinical trial oversight, particularly increased variability in clinical investigator experience, site infrastructure, treatment choices, and standards of health care, as well as challenges related to geographic dispersion. “ Watch how to resolve this issue!

Safety evaluation is crucial in all stages of drug/medicinal product development from preclinical to all stages of clinical trials prior to the marketing authorization to protect the health and wellbeing of patients treated with the product after market approval. Safety Data collection and reporting to responsible authorities should be done in a timely manner. But Why is such crucial data still reported via paper? Is this a sensible way to handle safety information that should be accurate, legible, and be reported sometimes even within hours for a continuous vigilance of the products’ safety?
Aside from the flexibility, agility and easy access, Online Trainings become more and more popular and highly effective as digitalisation advances as over time more and more tools also become available to develop more sustainable digital learning strategies to expand e-learning opportunities. Virtual trainings do not completely replace the benefits of face to face interactions but why could we all use a switch to e-learning?
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Many Biotech and Medical Device companies struggle with selecting CROs to conduct their global studies. Small CROs lack global coverage. Large CROS can slow down the work progress of smaller innovative companies because of their big size. To resolve this dilemma, a group of small to midsize CROs founded the Association of International CROs (AICROS) as a perfect solution for sponsors who need to conduct global studies without global CROs.
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Medical devices in the USA are regulated completely differently than in the EU. Consequently these differences are experienced when US companies try to develop drug-device combinations in the EU like they would in the USA. Unfortunately many companies struggle and fail without a thorough understanding of the EU rules of both drugs and medical devices. Finding the right partner is essential to get clinical projects with combination studies started.
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It is clear, that over the years clinical monitoring has shown an overreliance on traditional onsite monitoring to review source data, maintain high data quality/integrity and safeguard patient’s safety. But is 100% SDV the most effective method of ensuring clean data? The challenges and complexities faced in modern trials reflect a growing need to implement more agile approaches and incorporate centralised and remote approaches. Find out why our Remote Clinical Data Monitoring strategies, implemented way before Covid-19 pandemic, continues to show great benefits in keeping trial oversight
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Whether it’s a urine dip test strip or HIV/Hepatitis diagnostic test, over the years, In Vitro Diagnostics (IVDs) become more and more important in diagnosing health and disease or even monitoring therapeutic procedures. Explains the stricter regulations and quality standards put in place requiring even more clinical data! It’s important to understand IVDs regulations (IVDR) and hence why for your next IVD study you will need to contact the IVD task force group!
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Clinical Trial Planning, Statistical Concepts, and Interpretation of Data: How can we explain this for Non-statisticians? In our new video-series every other week, provided by our biostatistics team at GCP-Service! In maximum 5 Minutes we explain all around statistics in clinical research on a different topic each week, focusing on the bigger picture.

Quality Risk Management

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Quality Risk Management should be interesting for everybody in clinical research. For information about risk assessment and how to get study risk controlled take a look into our pragmatic video guide. Get a deeper insight into this topic with our video guide presented by Dr. Andreas Grund. Due to the complexity this topic is divided into 5 video parts, this is part 1

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Quality Risk Management should be interesting for everybody in clinical research. For risk assessment and to get study risk control take a look at our video series as pragmatic guide. Get a deeper insight into the topic with our video series with Dr. Andreas Grund.

Quality Risk Management should be interesting for everybody in clinical research. For risk assessment and to get study risk control take a look at our video series as pragmatic guide.Get a deeper insight into the topic with our video series with Dr. Andreas Grund. Due to the complexity this topic is divided into 5 video parts, this is part 3

Quality Risk Management should be interesting for everybody in clinical research. For risk assessment and to get study risk control take a look at our video series as pragmatic guide. Get a deeper insight into the topic with our video series with Dr. Andreas Grund.
Due to the complexity this topic is divided into 5 video parts, this is part 4.

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Quality Risk Management should be interesting for everybody in clinical research. For risk assessment and to get study risk control take a look at our video series as pragmatic guide. Get a deeper insight into the topic with our video series with Dr. Andreas Grund.
Due to the complexity this topic is divided into 5 video parts, this is part 5.

Medical Devices:



Clinical Evaluation of Medical Devices prior and after MDR Prior and after the new MDR there will be a lot to consider in the Clinical Evaluation of Medical Devices. What are the differences between MEDDEV and MDR? How to plan your clinical evaluation? What do you have to consider to get best results? How to keep your device on the market or get a new device on the market? Find some answers and advice in our interview with Dr. Andreas Grund and Dr. Jiří Paseka.

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New challenges for clinical research with medical devices! With the new MDR more than ever the focus in medical device studies should be on safety reporting and clinical performance. What are the important things we must not overlook? Find out in our interview with Dr. Andreas Grund and expert Gayane Kiragosyan.

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Neben der neuen europäischen MDR gibt es auch andere wichtige Änderungen z.B. im Einreichungsverfahren durch das neue deutsche Medizinproduktegesetz. Welche Auswirkungen gibt es noch auf klinische Studien, auf was sollte man in den eigenen Studien achten oder bedenken? Finden Sie es heraus in unserem Interview mit Dr. Andreas Grund und Experte Marcel Müller.

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Die neue MDR der EU im Detail – was ist neu?

The new MDR in detail – what’s new?

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Die neue Medizinprodukte Verordnung der EU ist da – was bedeutet das für die Entwicklung neuer Medizinprodukte? Unterschiede und Überschneidungen zu der Medikamentenentwicklung?

The new EU Medical Device Regulation is active – what does that mean for the development of Medical Devices? Differences and overlaps to Drug Development?

Jobs in Clinical Research:



Project management is an important part in in every clinical trial, but what is a normal day of a Project Manager looking like? How is a PM thinking? What does a PM have to consider? How to become a good PM? Is project management maybe a job for yourself? Find out some answers in this interview with Dr. Andreas Grund and Head of Project Management Sergej Graf!

GCP-Mindset: Daily life of a Data Manager Data Management is an important part of clinical research but what is a normal day of a Data Manager looking like? What does a DM have to consider? With whom is a DM working together? What kinds of interests should you have to start your career as a Data Manager? Find out some answers in this interview with Dr. Andreas Grund and Data Manager Anh Viet Anh Nguyen!

There are many opportunities and some limitations of Remote Clinical Data Monitoring. Find out more about effectiveness, costs and what makes Remote Monitoring so interesting. Will Remote Monitoring replace all on-site monitoring tasks in the future? Get some answers in this interview with Dr. Andreas Grund and Carol Lazovic.
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The CRA (Clinical Research Associate),also called clinical monitor, is a health-care professional who performs many activities related to clinical trials. The CRA’s task is to check and ensure data quality and regulations, including the Helsinki Declaration, implementation of Good Clinical Practice (GCP) and compliance with the study protocol. Monitoring can significantly improve data quality in clinical studies. But what is a CRA doing on a normal day? Find out some answers in this interview with Dr. Andreas Grund and CRA Bianca Seifert!

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Was hat sich im Bereich Clinical Monitoring in den letzten Jahren geändert?

What has been changed in Clinical Monitoring during the last years?

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Was ist Product Safety und wie gehen wir dieses Thema am besten an?

What does Product Safety mean and how do we approach this topic?

Biostatistics:



Was genau ist Centralised Monitoring und wo liegen die Vorteile für die Klinische Forschung?

What does Centralised Monitoring mean and what are the advantages for clinical studies?

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It’s a tough time for the Medical Device Industry. First the new MDR with many changes and now the update of the ISO 14155: Another challenge for clinical research with medical devices. Especially in the field of biostatistics we have to find ways to make the data more robust. How can we react on the new requirements? Find out in our interview with Dr. Andreas Grund and expert Dr. Andreas Beust.

Adaptives Studiendesign und Multiple Testing Procedures: Ein unerschlossenes Gebiet das enormes Potenzial für die Durchführung Klinischer Studien birgt.

Adaptive Designs and Multiple Testing Procedures: A new and uncertain territory that bears enormous potential for the conduct of clinical trials!​

Variable or parameter? In our new video we explain the differences and show examples for clinical trials. We also demonstrate what distinguishes surrogate variables from usual ones, and what criteria they have to fulfill, to be used as such.
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How can we get a good overview of our data in an easily accessible way? With absolute, relative and cumulative frequencies of occurrence. We explain what the differences are and what we can use these frequencies for. We also show you which frequencies hold most information. Coming up in our new video!

What kind of variable are we dealing with? Is it measurable or countable and therefore of quantitative nature? Or is the data given in classes, indicating qualitative variables? In our new video we will explain with practical examples for clinical studies what the differences are, and how to clearly distinguish these two data types.

Study Key Processes:



Was genau ist Centralised Monitoring und wo liegen die Vorteile für die Klinische Forschung?

What does Centralised Monitoring mean and what are the advantages for clinical studies?

Die Rolle des Zentrallabors ist besonders für multizentrische Studien von großer Bedeutung – erfahren Sie in unserem neuesten Interview mehr darüber!

The role of the central laboratory is of great matter, especially for multicenter studies – learn more in our newest expert interview!

Welche Einflüsse hat das EMA Reflection Paper on TMF Management und ICH (R2) auf den täglichen Umgang mit dem Trial Master File.
Which impact has the EMA Reflection Paper on TMF Management and ICH (R2) on the dialy work with a TMF?

Global study information:



Was sind die Besonderheiten von klinischen Studien in Australien?

What are the special characteristics of clinical trials in Australia?

Was sind die Besonderheiten von klinischen Studien in Mitteleuropa?

What are the special characteristics of clinical trials in Central Europe?

Klinische Studien in Bulgarien und Rumänien – welche speziellen Eigenschaften diese beiden Länder mit sich bringen erfahren Sie in unserem aktuellen Interview.

Clinical Trials in Bulgaria and Romania – learn about the special characteristics these countries bring with them when it comes to clinical research.

Klinische Studien in Portugal, Spanien und Italien – welche speziellen Eigenschaften die südeuropäischen Länder mit sich bringen erfahren Sie in unserem aktuellen Interview.

Clinical Trials in Portugal, Spain and Italy – learn about the special characteristics the southern european countries bring with them when it comes to clinical research.

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Poland is one of the most underestimated countries in europe for medical trials. What are the special characteristics of Clinical Trials in Poland? Why is Poland so interesting for Clinical Research? What are the facts? Find out in our Interview with Dr. Andreas Grund and Dr. Joanna Wilinska-Mackowiak

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Albania, the hidden gem for Clinical Trials? What are the advantages for Clinical Trials in Albania? Which studies can be carried out particularly well there? What do you have to pay attention to? Find out a few answers in our interview with Dr. Andreas Grund and the expert David Rosenbaum.

Electronic Data Capture (EDC):



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Die traditionelle Papier-basierte Datensammlung wird in klinischen Studien mehr und mehr von Electronic Data Capture (EDC) ersetzt. Welche Vorteile kann EDC in klinischen Studien mit sich bringen?

The traditional paper-based data collection is replaced more and more by Electronic Data Capture (EDC) in clinical trials. What can EDC provide in clinical trials?

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Software Development bietet mehr und mehr Chancen in der klinischen Forschung. Erfahren Sie mehr in unserem Experten-Interview mit Prof. Jörg Mielebacher und Dr. Andreas Grund.

Software Development offers more and more opportunities in clinical research. Watch our new expert interview with Prof. Jörg Mielebacher & Dr. Andreas Grund.

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The electronic investigator site file (eISF) has many advantages compared to paper-based procedures. What are the potentials of an eISF and how is the compliance effected? Find the answers and more in our interview with Dr. Andreas Grund and expert Benjamin Tsiflidis.

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In clinical trials electronic Patient Reported Outcome (ePRO) is more and more a commonly used method. Electronic diaries or pain scales, web based or via smartphone app, there are some differences you should know and understand. Can ePRO improve compliance? How is the patient acceptability? Is the need for manual editing of data eliminated? Find the answers and more in our interview with Dr. Andreas Grund and expert Dr. Sebastian Fessel.

Other special topics:



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The Role of Biostatisticians in Clinical Trials: Tasks and Responsibilities Involving Biostatisticians in all aspects of clinical evaluation already from the planning phase of a clinical trial can save you time and money! In this video we bring clarity on: -Why Biostatisticians should be involved from the very beginning of a clinical trial? -Tasks and responsibilities? -How Biostatisticians can help make your trial more efficient and successful? Find all the answers in our new video!
Warum ging die Impfstoffzulassung bei Corona-Impfstoffen so schnell?
Normalerweise dauern die Entwicklung und die Zulassung von Impfstoffen Jahre. Viele fragen sich jetzt zurecht: „Warum ging das beim Corona-Impfstoff so schnell? Und sind die Risiken und Nebenwirkungen wirklich ausreichend erforscht?“. Ein paar Antworten findet ihr im Video.
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How can we get a good overview of our data in an easily accessible way? With absolute, relative and cumulative frequencies of occurrence. We explain what the differences are and what we can use these frequencies for. We also show you which frequencies hold most information. Coming up in our new video!
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South Africa is one of the most developed economic areas on the African continent and therefore of course an interesting place for clinical studies! Which studies can be carried out particularly well in South Africa? What do you have to pay attention to? Find out a few answers in our interview with Dr. Andreas Grund and the experts Dr. Frank Ativie and Stephen Nenwa.

Africa is the second largest continent after Asia and has a population of over 1.3 billion people spread across 55 countries. Which of these countries are particularly suitable for clinical studies? What should you watch out for? Which studies can be carried out particularly well in African countries? Find out a few answers in our interview with Dr. Andreas Grund and the experts Dr. Frank Ativie and Stephen Nenwa.

What are the advantages for Clinical Trials in Scandinavia? Which studies can be carried out particularly well there? What do you have to pay attention to? Find out a few answers in our interview with Dr. Andreas Grund and the expert Helene Quie from Qmed Consulting!
India has more than 1.3 billion inhabitants. Is it a good place for clinical trials?What are the advantages for Clinical Trials in India? Which studies can be carried out particularly well there? What do you have to pay attention to? Find out a few answers in our interview with Dr. Andreas Grund and the expert Deepa Arora, Director of CLINEXEL Life Sciences Pvt Ltd.
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In times of the Corona Pandemic clinical trials are a challenge. What do we have to consider, what are the regulatory aspects? From the start-up phase of new clinical trials, remote monitoring to close-out visits. Find some answers given by Dr. Andreas Grund.

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Prüfärzte müssen für die Teilnahme an klinischen Prüfungen entsprechende Fortbildungen mitbringen. Welche genau und was es zu beachten gilt in unerem neuen Video.

Investigators need further training to participate in clinical trials. Find out more about the requirements in our new video.

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What is modern Quality Assurance, what is Quality Control and what has it to do with our Audits, Findings and Quality Management? What do we have to keep in mind for better and effective Quality Assurance? Find the answers and more in our interview with Dr. Andreas Grund and expert Petra Štěpánková.

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Bei der klinischen Prüfung in der ästhetischen Medizin gibt es viele Aspekte die für die Zulassung wichtig sind. Ein Interview mit der Expertin Edith Kron und Dr. Andreas Grund.

A variety of things play a role in aesthetic medicine clinical trials. An interview with our expert Edith Kron and Dr. Andreas Grund.

Klinische Prüfung in der Verkehrsmedizin - spannende Einblicke in eine unbekannte Nische!
Clinical Studies in traffic medicine - find out more about this exciting niche topic!

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In times of the Corona Pandemic clinical trials are a challenge. What do we have to consider, what are the regulatory aspects? What advices do we get from the FDA and EMA? Find some answers given by Dr. Andreas Grund.​

Outsourcing ist ein wichtiges Thema in der klinischen Forschung, aber was ist effektives Outsourcing? Outsourcing in clinical research is an imporant topic, but what makes Outsourcing effective?

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GCP Mindset: Worüber wollen wir sprechen?

About which topics do we want to talk?

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4 basic questions regarding EU Legal Representation for clinical trials.

Was bedeutet das FSP Modell und wie funktioniert es? What does FSP mean and how does it work?

About our philosophy, processes and tools


About GCP-Service International

The advantages of online training in clinical research

Electronic feasibility studies lead to better and more robust data (with Pi-Select)

How QCTMS can help you to run your study better (Quality Controlled Trial Management System)