Global Compliance and Support for Clinical Trials
Biotrial offers a complete range of pharmaceutical affairs services to support clinical trials in the US and France.
Our global team of experts has the experience and expertise to support clinical trials of all types and sizes. We are committed to providing our clients with the highest quality pharmaceutical affairs services.
Our in-house pharmacies are GCP-compliant and offer a wide range of pharmaceutical services for different types of Investigational Medicinal Products (IMPs, new chemical entities, biologicals, ATMPs, herbal medicines, food Supplements, and Medical Devices) including:
Biotrial’s pharmaceutical service oversees all steps of the product process from drug supply, drug import, receipt, storage, accountability, compounding, over-encapsulation, repackaging, relabeling, dispensing, reconstitution of sterile injectable solutions, reconciliation, and destruction or return.
Both of Biotrial’s pharmacies follow the same processes, which can be adapted to follow different regulations in Europe and the USA.
Similarities
American Pharmacy
French Pharmacy
Biotrial provides drug import and European certification services for clinical trials. For drugs not manufactured in Europe, we partner with a Qualified Person (QP) to conduct drug analysis and obtain the European QP release for approval, ensuring compliance with all applicable regulations and the highest standards of quality and safety.
Biotrial’s experienced pharmacists can prepare different dosage forms of Investigational Medicinal Products (IMPs) and Medical Devices, such as tablets, capsules, oral solutions, and injections.
We use the same type of capsules, filled with the main excipient only. This ensures that the capsules are consistent in appearance and taste, which can help to improve patient compliance.
We use NaCl for IV or subcutaneous formulations. This is the most common salt used in injections, and it is known to be safe and effective. We also use amber syringes if the drug infusion is colored. This helps to protect the drug from light, which can degrade its effectiveness.
We encapsulate the test tablets in a capsule and make an identical encapsulated placebo. This allows us to blind the study participants to whether they are receiving the active drug or the placebo.
We mask the taste (acid, bitter…) by using ancillary products such as mint strips, sugar, or bitter solution. This helps to make the oral solutions more palatable for patients.
Biotrial takes great care to ensure that sterile drugs are handled safely and securely. We have a dedicated team of pharmacists who are trained in sterile drug-handling procedures. We also have a state-of-the-art clean room facility that is classified as ISO 7 under positive pressure.
Biotrial ensures the safe handling of non-sterile drugs with trained pharmacists and a dedicated preparation room with air extraction.
Non-sterile
Biotrial’s pharmacy team is composed of two teams, one located in the US and the other located in the EU. The team works together to ensure the safety and proper conduct of clinical trials.
Biotrial’s experienced pharmacists can prepare different dosage forms of Investigational Medicinal Products (IMPs) and Medical Devices, such as tablets, capsules, oral solutions, and injections. They have a deep understanding of the pharmaceutical industry and they are committed to providing the highest quality pharmaceutical preparation services.
The pharmacy team is well-experienced and fully trained in Good Clinical Practice (GCP). They can manage all pharmaceutical operations according to client requirements. This includes:
