Learn how can you lay the groundwork for the clinical development of your product with our Contract Research Organization
As we mentioned in our last article conducting a Clinical Trial can be daunting. At HEMEX, we know that, and for this reason, we have prepared an offer you should definitely consider. If you are planning on generating the accurate evidence needed for your product’s regulatory and commercial success, you have landed on the right article. If not, stay in the loop; information is power! Many of you have asked us for the best way to conduct your clinical trial. Therefore, our Clinical Operations experts have prepared the following guide for you. With this practical guide divided into three articles, we will explain the important aspects you need to have covered. Today, we are focusing on how you should PREPARE for this journey in your clinical development. Here are 5 necessary steps that will help you start advancing your innovation:
- Lay a strong foundation with a scientifically sound study design
As it is said, well begun is half done, study design is all the more important as this determines the tone for the entire clinical study. Firstly, you need to start with clear ideas as to what you want to achieve with the study, which then should be translated into quantifiable study objectives. If the study is planned with a goal of eventual market access, the study objectives and design must also meet all the applicable regulatory requirements.
- Identify the Key Opinion Leaders (KOLs) in the field
The next step is to approach the experts in your field because nothing can replace their experience and their insights will play a pivotal role in planning the study. With their guidance, you can identify your study population and an appropriate comparator. Apart from the phase I studies, the study population must represent your targeted population post-market.
- Be sure to involve a biostatistician as well in this process
They will support you with sample size calculations, which will impact the budget, timelines, and very likely the number of sites you need for the study. Apart from defining endpoints according to the objectives, a biostatistician will also help you define other minor but crucial details of the study design like randomization, blinding, and stratification strategies.
- Identify potential investigational sites
It is important to assess the experience, infrastructure, recruitment rate, and related costs to determine the suitability of the site to fulfill study-specific requirements. Once the sites have been selected, local laboratories, vendors, and logistics partners can be chosen. At this point, it would also be beneficial to think about a monitoring plan outlining the frequency and timing of remote and on-site monitoring visits.
- Do not forget about the study documentation
While all study-related activities are going on in the real-world, it is important to also keep up with the study-related documentation. Apart from the obvious reasons for fulfilling regulatory requirements and submissions, producing high-quality study documentation is essential for traceability, transparency, reproducibility, and trial coordination. These study documents include:
- Study protocol, CRF, patient information, and consent
- Product related documents like IMPD/IMDD, Investigator’s Brochure, Instructions for Use
- Clinical trial management documents like communication plan, monitoring plan, and data management plan.
Once you have everything in order, you can submit the study to local Ethics Committees/Institutional Review Boards and if applicable, the national regulatory authorities. When you get the approval for the study, a site initiation visit can be performed to train the study staff and ensure the study is equipped with the investigational product.
You are now ready to recruit your first patient!
At HEMEX, we support clients globally across multiple sectors, including Pharmaceuticals, Biologics, Medical Devices, In Vitro Diagnostics, and Digital Health solutions. We have the experience in a variety of human and animal therapeutic indications, gained through more than 200 projects. We can help you launch your project with our PREPARE package, which meaningfully covers all the steps mentioned above and more!
We can also help you at each critical step of your clinical development, you will discover what’s included in the CONDUCT and REPORT packages in the next articles. Stay tuned!
Can’t wait? Get a peek at the other packages HERE!
HEMEX AG is committed to changing the future of healthcare by guiding the most promising European start-ups through each and every step to bring innovative pharmaceuticals, medical devices and in vitro diagnostics to the market. Headquartered close to the thriving Basel global Life Sciences hub, the goal at HEMEX is to ensure start-ups have access to a wide range of tailored products, practical solutions and fundraising support. This empowers the next generation of transformative discoveries to grow into successful and sustainable businesses, and drive change in both human and animal healthcare. For more information, visit https://hemex.eu/