QP Release Services
According to the new Israeli MoH regulations all IMP for clinical trial use must be released by a local QP. Trialog has in house authorized QP pharmacists who can perform QP release in accordance with all the requirements of the new regulations.
Import & Export
Trialog’s experienced Import & Export team can handle all import regulatory requirements and customs release services. Besides obtaining all the necessary licenses for the import of our clients investigational drugs, including narcotics drugs and medical cannabis, Trialog can facilitate the release of non-drug supplies that are required for the clinical trial from laboratory kits through all medical equipment and electronic data collection devices such as e-diaries. In addition, Trialog can manage the export of all clinical trial materials either at the end of the study or during the course of the study as required.
Clinical Trial Materials Purchases
Trialog can assist clients who wish to source comparator drugs or other clinical trial materials. Trialog purchases only from approved suppliers. Clients can be confident that purchased material will meet the standards required for their clinical trials.
Trialog understands that proper storage designed to maintain the integrity of all clinical trial materials is essential for the success of the clinical trial. Trialog offers a wide range of storage temperature options to meet our clients specific needs.
Ambient: (15 -25°C)
Deep frozen: (-80°C)
All areas are continuously monitored to ensure that required temperature range is maintained, and Trialog works with each customer to guarantee that his clinical trial materials are stored exactly in accordance with the study requirements, Trialog offers secure storage solutions for controlled substances such as narcotics drugs and medical cannabis.
Trialog distributes clinical trial materials (CTM) to all hospitals and clinics in Israel. A full range of services is provided including emergency deliveries to ensure that CTM is at site when needed. Distribution is performed by the Pharm-Up group fleet of validated vehicles, all of which have advanced air-conditioning and ambient temperature recording as well as GPS tracking systems. Dispatches are tracked, confirmations of receipt at site are returned to Trialog, and the signed confirmations are then forwarded to client. All drivers are trained in the special needs of CTM distribution to ensure that shipments are always delivered in good condition to the designated person at the site.
GMP LABELING & MANUFACTURING ACTIVITIES
Trialog has a dedicated GMP department for primary and secondary relabeling and repackaging. In addition to help our clients meet a variety of needs, we have recently added a range of manufacturing activities including over encapsulation, manufacturing of placebo capsules and blinding/randomization of kits. The department is managed by a Trialog pharmacist. It is inspected and approved by the Israeli MoH as GMP certified. Trialog’s expertise in performing a variety of relabeling operations means the lead time for delivery of clinical trial materials to sites can be kept to a minimum.
Returns & Destructions
Trialog maintains a separate Quarantine/Destruction area for clinical trial materials returned for further storage, destruction or export according to client instructions. Trialog can perform reconciliation services as needed and can work with external IVR systems to track collections and destructions. All destructions are performed in strict compliance with GMP and local MoH requirements.
Trialog can track the supply chain of the product down to the kit level from the moment the medication arrives at Trialog till it is delivered to site and returned to Trialog as required.
Trialog offers customers Business Intelligence (BI) capabilities. Clients are offered various reports updated in real time, such as Accountability capturing all study activity, Returns and Destruction, Current Inventory, Order Status etc.
This information helps clients to monitor study activities hands on for optimal managerial decision making.