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Ask Archer | Tips towards clinical data that meet all regulatory requirements


Nowadays, conducting clinical studies with medical devices has become more and more complex due to both international requirements, like the MDR and ISO standards, and national requirements.


In our Ask Archer interviews, we put our own experts in front of the camera and asked them for their tips and tricks for a stress-free journey towards clinical data that meet all regulatory requirements.



"How do you stay within the timelines and budget of your clinical study? Why do you need to monitor clinical data? How to make sure you are ready for an inspection of your study?"

Keep an eye on this page or follow our LinkedIn account, as our experts are more than happy to share their perspective on these and many other questions the coming months.


 



Why do you need to keep oversight of your clinical study?

Frea Coun


Frea reveals what a CRO can do to help you keep oversight of your clinical study, and ultimately contribute to the success of your clinical study.





Top tips on how to successfully publish clinical data in your preferred peer-reviewed journal.

Dorien Haesen



You hold valuable clinical data that you'd like to be published by your preferred peer-reviewed journal. But where do you get started? Dorien, our Clinical Research Professional, shares with you 4 top tips on how to make this happen.



1. Choose your journal wisely.

  • Journal impact factor should match the strengths and weaknesses of your research and your manuscript.

  • Follow the journal’s instructions.

  • Consider the relevance of your results to the readers of the journal. Find the best match.

2. Present reliable data - make sure that your study is planned and carried out well.

3. Keep a sharp eye on your abstract, tables and figures - to make a good first impression on the editors.

4. Surround yourself with professional medical writers - knowledge and experience of the medical writers of Archer Research CRO will speed up the publication process by delivering high quality papers that meet the requirements of the chosen journal.




Are we reaching a regulatory harmonization in clinical studies with medical devices yet?

Mieke Tempels


Can you start up a clinical study in every country of interest if you comply to the ISO standard for clinical studies for medical devices and the Medical Device Regulation or MDR? The answer, however, is nuanced. Our Quality Manager Mieke advises you on how to set up clinical studies in different countries.




Why do you need to monitor clinical data?

Clotilde Thumser-Henner


"Clinical data monitoring might be an important consideration in the clinical study budget, but it ultimately avoids unnecessary costs and project delays." Clotilde, our Clinical Research Associate, explains why monitoring is vital for your data quality and ultimately for the patient's rights and well-being.





How does a personal approach benefit your clinical study during study conduct?

Stephanie De Munter

When being in contact with medical device companies or with site staff working on clinical studies, we often hear that they experience a lack of communication by persons involved in project planning and management.


At Archer Research, we guarantee timely and transparent communication with all parties involved in the study. This can be done via a simple phone call, by planned (virtual) meetings, by organizing investigator meetings or by sending out newsletters summarizing the study progress and important information for the whole project team. By doing so, our goal is to keep everyone involved, to pick up any challenges as soon as possible and to ensure the project is on top over everyone’s head.


Furthermore, we avoid project turnover within our team. If someone of our team is assigned to your project at the start, he/she will also be the person you finalize your project with. In this way, we avoid crucial information about the project being lost over time and we ensure a smooth study continuation.


Because good communication is one of Archer’s key pillars, tracking sponsor and site staff experiences with our staff in terms of communication is part of our quality system. Nice asset: 97% of the people that completed our surveys are extremely satisfied with our professionalism and way of working.



What are the critical factors that can make or break your study timelines and budget?

Dorien Haesen


Setting and maintaining realistic deliverables and timelines for your clinical study is no sinecure. Dorien, our Clinical Research Professional who has been working with us for more than 6 years, shares with you 5 top tips on how Archer can help you safeguard your study timelines and in consequence, the budget.


  1. Realistic project estimation – Identifying project requirements, having experience in the indication, setting realistic study budget and defining realistic study milestones together with our sponsor from the very beginning.

  2. Quality by design – Building quality in the scientific and operational processes to maximize efficiency and minimize risks, focusing on the critical data and processes.

  3. Proper site and investigator selection – Ensuring participation of qualified and committed site staff with adequate resources, facilities and participant availability.

  4. Adequate project management – Creating and tracking clear and achievable project objectives, managing the constraints for projects (timelines, milestones, budget, …), providing frequent project status to study team and sponsor.

  5. Managing and communicating risks throughout the project – Increasing the success of the study by proactively identifying potential issues and devising well-considered solutions.


How do you stay within the timelines and budget of your clinical study?

Mieke Tempels


Medical device companies often define their timelines based on the development stage of the product, as well as the budget planning. It is, however, also crucial not to lose sight of the study specific timelines and milestones. Let Mieke or her fellow Research Professionals advise you in setting realistic timelines for your clinical study.



How to make sure you are ready for an inspection of your study?

Frea Coun


Good Clinical Practice, ISO standards, national and international regulations,... we understand that taking all this into account for your clinical study documentation can be overwhelming. Frea, our Clinical Trial Assistant, knows the ins and outs on how to make studies inspection proof and is all too happy to help you out with this. Contact her for customized advice for your business: info@archerresearch.eu




What Are the main drivers of a clinical study budget?

Karen Gabriels


Nowadays, conducting clinical studies with medical devices has become more and more complex. Therefore, preparing a budget plan for your clinical study can be difficult and time consuming. Our Clinical Research Manager Karen knows like no other how to create a successful budget plan and, ultimately, deliver data that is mutually accepted by the authorities and your clients.



What are the disadvantages of working with a smaller-sized CRO like Archer?

Clotilde Thumser-Henner


"We might be small, but we perform everything in-house. This is our strenght." Our Clinical Research Associate Clotilde on why being smaller-sized as CRO just works for us.




Why is it important to integrate risk management in the conduct of your clinical investigation?

Dorien Haesen



Do you need to integrate risk management in the conduct of your clinical investigation? It's a must if you ask our Clinical Research Professional Dorien! She tells you why in 5 helpful tips.



  1. The adaptive approach to clinical study monitoring focuses on the areas of greatest need which have the most potential to impact subject safety and data quality.

  2. To control, as much as possible, future outcomes by acting proactively rather than reactively.

  3. Because of the 4 essential steps of the risk management process are: Identify the risk. Assess the risk. Treat the risk. Monitor and Report on the risk.

  4. To allow a more detailed assessment of the project management and monitoring in the study, which is beneficial in improving the quality of the study and the safety of clinical study participants.

  5. When using a CRO, having the knowledge, capabilities, processes and procedures for efficient implementation of risk management, this will lead to reduced timelines as well as reduced costs for your clinical investigation.



How does a personal approach benefit your clinical study during study start-up?

Stephanie De Munter


Designing clinical studies that meet all national and international regulatory requirements is expert work and therefore a common pitfall for medical device companies interested in collecting clinical data. When new projects are discussed with a study sponsor or an investigator, my colleague research professionals and I are getting in the picture at the very beginning. As experts in clinical studies with medical devices we challenge them by asking the right questions, which helps us in finetuning their study design, feasibility and set-up.


Besides that, we also make sure that the expectations are clear from all sides before the project starts. By having these regular contact moments in the start-up phase, we create a partnership spirit in which all company cultures are important and no one should hold back to pose additional questions or to open a new discussion.



How to keep a financial oversight during a clinical study?

Frea Coun


"At all times sponsors are kept in het loop on the study progress, also budget wise, no surprises". At Archer we value a personal aproach with short lines of communication. Our Clinical Trial Assistant Frea is happy to share with you her tips and tricks for you to keep a financial oversight during your clinical study progress. Contact her via info@archerresearch.eu.




How do you select the right investigators for your clinical study?

Mieke Tempels


In order to minimize the risk and ensure a good collaboration from the get-go, we follow our well-established procedure to verify site and investigator feasibility. Mieke, on board at Archer for more than 7 years, explains.




Get in touch


Do you have additional questions for our experts? Or would you like personalized advice for your project? Do not hesitate to reach out, we hope to hear from you soon!




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