“The Swiss are renowned for expert precision work and timeliness. At Fisher Clinical Services we not only offer Swiss precision, but also the flexibility of a multicultural service environment.
The clinical supply chain is composed of a series of functions that map onto an integrated network responsible for the packaging, labeling and shipment of investigational drugs, as well as the management of re-supplies and returns from around the world. Having the infrastructure to accomplish this is no small task and requires a team of skilled experts across a multitude of disciplines; annual training and certification; state-of-the-art equipment, systems and processes.
With over 20 years of global supply chain experience in clinical trials, we welcome you to find out more about our facility and the benefits extended to Sponsors. We invite you to read our case studies on innovative technology and comparator sourcing expertise.”
Astrid Frank, Vice President & General Manager European Clinical Services
Pioneer in production automation
Location: 53mi/85km NW of Zurich
Nearest Airport: EuroAirport Basel (BSL)
Distance from Airport to Facility: 6.9Km
Fun Fact: Here you can visit the World Famous Johann Wanner Christmas Shop. The shop is located in the centre of Basel, and is open throughout the year. They have decorated the Rockfeller Plaza. The shop’s most famous client is the Queen of England.
Key Benefits for Sponsors:
A large multinational pharmaceutical company was looking for a partner to help prepare for a new clinical trial in the US and Europe.
The Challenge The Sponsor had pre-filled syringes for this trial which needed to be labeled, packaged and distributed worldwide. A unique solution was required as this trial demanded extremely precise label application on syringes of varying lengths. Manual label application was not considered accurate enough. Full automation of the labeling process was the only option acceptable by the Sponsor. Each label needed to be applied in a certain position on each syringe to reflect the correct dosing information. If not, the patient could receive an incorrect dosage which could put the patient at risk and compromise the trial.
The Solution Fisher Clinical Services initiated a feasibility study to take into consideration all aspects of this complex and unique project. The recommendation was to develop a new machine to eliminate the risk of getting it wrong. Technical specifications were drawn up for this new syringe labeling machine to apply, with very high precision, labels containing a dosing scale. This meant using a special camera system to indicate the bottom of the syringe for precise label application. The permitted deviation of the label position was only +/-0.7mm. In addition, due to the required high precision of the label appllication, the Fisher Clinical Services team of experts needed to offer a new type of high precision label to ensure better results.
Due to the critical nature of this project, an automatic discharge of the syringes from the machine was required. In the case of rejects, products with a label out of specification, would be sent to a sensor controlled reject exit. All other syringes would go through an automated quaility control which involved re-measuring the zero position of the syringe and checking on exact label position after application.
As the project required variable data to be printed on the label, the machine needed the capability to print and apply data on-line. In order to fulfil this request, the printer needed to be set up to acquire all variable data from the database whenever it was needed. And finally, the system needed to provide the capability to reprint missing or illegible labels and to create a report of rejected labels into an audit trail.
Development The Fisher Clinical Services Engineering Team developed this new equipment to meet the unique requirements of the Sponsor. Due to the demographic reach of the trial, the decision was made to build two new machines – one for Basel, Switzerland for the European sites, and one for Allentown, PA, for the US sites. After labeling and packaging was completed the patient kits were distributed to these sites worldwide. The project took just 5 months from approved customer requirements to equipment build and quality control checks, ensuring First-Patient-In dates were met in Europe and in the US.
Innovation, Efficiency & Cost Savings The first version of the machine was able to define the label position accurately in relationship to the bottom of the syringe, but with a reject rate of circa 10%. The Sponsor, now aware of the Fisher Clinical Services team’s expert capabilities, challenged the team to decrease the rate to below 10%, because the cost of rejected syringes was still quite significant. Further engineering modifciations to the machine dramatically reduced the reject rate from 10% to below 2%. This provided the Sponsor with an 8% saving of time and money. Today the machine runs faster and has very few syringe rejects, if any.
Customer Satisfaction Patient safety is paramount for all clinical trials, but in this instance extreme measures had to be taken to ensure accurate precision labelling of syringes reflecting correct dosage levels. All timelines were met for this trial and the Sponsor is currently planning to use this innovative technology to prepare clinical supplies for future trials, globally.
A leading pharmaceutical company approached Fisher Clinical Services to assist them with obtaining comparator study medication for a global Phase III program. The trial was focused on an infectious disease and would involve 25 countries across 130 investigator sites.
In a previous program, the Sponsor had sourced comparator medication directly from the manufacturer, but as all sourcing was done via a central office the price for the study medication in Europe was expensive.
The Challenge The challenge for the Fisher Clinical Services team was to investigate whether it would be possible to source the comparator via alternative countries for use in European sites. Additional challenges included the high price of the comparator drug and the agressive timelines of the study.
Center of Excellence The Fisher Clinical Services Comparator Center of Excellence, based in Basel, is dedicated to sourcing comparator medication globally. With a strong network of colleagues in Western and Eastern Europe, North America, Latin America and Asia, the Comparator Center of Excellence team is able to tap into the global distribution and regulatory expertise from our fully owned resource network around the world. These resources have become critical assets when helping explore the opportunity or need to support supplying comparator and other study medication through or in emerging regions.
The approach The Fisher Clinical Services team first investigated whether or not it was possible to obtain the drug from any of the lower cost EU markets. The team then researched the US market. Initial research revealed that the product was available in the US, and at a cheaper price, approximately 15% lower than the price at which it was currently offered in Europe. Further research was conducted to verify if the product could be purchased and imported into the EU for further blinding and packaging. However, subsequent research revealed that the US version differed slightly in terms of its dilution and preparation. In addition, there was an additional hurdle to overcome – the importation and the Qualified Person (QP) release within the EU as the US had no MRA with the EU at the time.
A parallel sourcing approach In an effort to adhere to optimistic timelines, the Fisher Clinical Services team also investigated the availability of the comparator medication in emerging markets, including India and Turkey. The product was available in both countries – the US formulation in Turkey and the EU formulation in India. The team proactively obtained pictures and supporting documentation including a Certificate of Authorization (CoA) that specified that the product was actually manufactured in the EU under GMP conditions. The resulting approval became a great benefit as it provided the ability to re-import the product for clinical trials within the EU. The team defined a set of detailed procedures which included analytical testing and which adhered to the Sponsors Quality Assurance (QA) procedures.
End-to-end solution This cold chain comparator medication put additional demands on the Fisher Clinical Services team. It was essential to manage the transportation and handling of the product carefully, including selecting the proper shipping containers and transportation method to avoid any product contamination or loss due to temperature excursions. The Fisher Clinical Services team was able to co-ordinate the entire procurement, transportation, receipt and packaging for the Sponsor from beginning to end, meeting the Sponsor’s deadlines and reducing the original estimated budget by 20%. Fisher Clinical Services continues to source comparator for this Sponsor.