Specialty services
Clinigen’s long-standing experience with specialty services such as On-Demand Packaging & Labelling, Direct-to-Patient (DtP) and Investigator Initiated Studies (IIS) services is what sets us apart from other clinical trial logistics providers. Our teams are comprised of seasoned clinical supply experts with in-depth industry knowledge, which enables a personalised approach to our clients’ trials. We work with our clients to deliver tailored solutions, advising on the best clinical supplies management strategies for their trials. Depending on the specificities of the project, the below premium services may greatly increase the efficiency of a trial.
Our On-Demand model
We recognise the packaging and labelling obstacles you face for your clinical trials, from time constraints to study changes that cause re-work and waste. With Clinigen’s On-Demand method, you will be able to shorten timelines, reduce clinical trial costs, and increase the flexibility of your study to tackle any packaging and labelling difficulties directly from the start.
On-Demand and study enrolment
On-Demand focuses on actual enrolment, allowing you to start a clinical trial in just a few weeks. This method includes the packaging and labelling of clinical supplies specifically for, and immediately prior to, each shipment request. Additionally, we make sure your On-Demand request will be processed and shipped within 5 days every single time; standard turnaround time depends on your location (EU or US).
On-Demand and waste reduction
Even with expense forecasting and implementing lean from the beginning, more than 25% of all clinical supplies that are packaged and labelled are never used. On-Demand packaging and labelling of clinical trial supplies specifically for, and immediately prior to, each shipment request eliminates this waste. This can allow you to save more than what you spend to package supplies for the entire clinical trial. It also reduces storage and inventory and makes adaptive trials possible.
While this premium service may be appropriate for small to large-scale trials, trials involving expensive and limited supply medicines, in particular, can greatly benefit from the On-Demand method.
As an example: In a recent study, a comparator drug of $5,000 per unit was ordered and dispensed On-Demand. Since much smaller quantities of the drug were needed, using On-Demand saved almost 70% compared to the traditional method.
On-Demand services: features and benefits
On-Demand clinical trial supplies are packaged and labelled after the receipt of the shipment request.
This process requires much less bulk drugs at the start. In fact, bulk drugs could be continually received in small allotments without affecting the On-Demand process. Once a shipment request is received, only the requested quantity is packaged and labelled. This can apply to primary packaging as well as secondary packaging.
The On-Demand Workflow for Clinical Trials
Within 24 hours, the following services will be automatically provided:
- Request: An IWR/IVR requests specific kits/blocks via fax or email. We can also customise this process in the event you aren't using an IWR/IVR.
- Dispense: The requested kits are packaged and labelled upon receipt of the request under cGMP conditions and are 200% checked for accuracy before release with an additional 100% oversight and final release by Quality Control.
- Ship: Up to 5 working days upon request, clinical trial material is shipped to study sites in a protocol specific pack out.
The On-Demand Difference
- Provides flexibility in product use
- Adapts easily to change and eliminates duplicate work
- Reduces drug waste
- Eliminates need for packaging campaigns
- Accommodates change without compromising the trial timeline
- Reduces storage and inventory
- Makes adaptive trials possible
- Greatly lowers the costs associated with clinical trials
Like our clinical packaging and labelling offering, our On-Demand service is responsibly performed under cGMP conditions and diligently follows the requirements of 21 CFR 211 and Annex 13.
Direct-to-patient logistics services
Patient enrolment and retention can be quite a challenge when dealing with homebound patients, an orphan indication, or a dispersed patient population. Clinigen has designed a Direct-to-Patient programme, which provides a highly customisable solution per patient and per protocol.
With a 10+ year track record in Direct-to-Patient, we have delivered over 8,000 DtP shipments to trial participants.
By meticulously designing these projects, we ensure our clients and their contractors are following the guidelines of GCP. Our team creates an individual logistics plan for each patient’s location to ensure smooth delivery and compliance.
Clinigen is carrier-neutral, and our Direct-to-Patient logistics pre-planning ensures your products are delivered at the right temperature and within the right guidelines.
Throughout each stage of the supply chain, our team ensures the privacy of patients, protecting patient health information.
DIRECT-TO-PATIENT BENEFITS:
- Gain access to a wider patient population
- Increase patient enrolment and retention
- Reduce patient trips to clinical sites
- Use of integrated courier sites
When used in conjunction with On-Demand Packaging and Labelling, Clinigen is able to dispense daily dosing for a product that has a very short shelf life. These innovative services are truly setting the pathway for personalised medicine.
IIS SERVICES
The Clinigen team has a unique perspective when it comes to Investigator-Initiated Studies services (IIS Services). We enable flexible processes that operate as if they were outside of a clinical study. In an IIS, competent national authorities require independence between the pharmaceutical company and the investigator. Ensuring that independence can be difficult when a study presents various and specific challenges for each party. Clinigen is well versed in handling these requirements all while ensuring the trial runs as smoothly as possible.
IIS distribution authorisations
When it comes to distribution, we have managed regulatory pathways required to facilitate the movement of materials in support of the IIS and EAP programs on an international level. Our authorised investigator-initiated studies included, for example, commercially packaged material (CPM) shipments for an EAP program to Australia and Canada.
In regards to the Australian government, the Department of Health issues a letter with the patient-specific information, which we include in each shipment as well as the Patient Access Form. For Canada, we have a Letter of Authorisation to ship materials to certain sites.
Take 20 minutes and connect with a comparator sourcing expert
As market leaders in Comparator Sourcing, Clinigen offers smart and flexible strategies to provide you with unrivalled access to medicines and ancillaries. From exclusive distribution agreements to On-Demand sourcing, we pioneer new supply strategies to help your trial run as efficiently as possible and eliminate long lead times.
Schedule a call with our experts