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Pharmaceutical Manufacturing and Packing Sourcer

Chain Control


IT system integration in the clinical trial material supply chain is often overlooked when establishing data management, but knowledge and consideration of the options available can greatly improve the reliability and efficiency of a trial logistics programme. According to research by Porsche Consulting, the average product development time in the automotive industry has fallen by 28 per cent in recent years, while in pharmaceuticals it has risen by 31 per cent (1). What causes this divergent evolution? Car manufacturers may not be under much pressure from insurers and regulators, but large biopharmaceutical companies are finding more upstart competitors moving in on their patch. However, part of the reason for prolonged cycles in drug development is generated in-house by the biopharmaceutical industry itself.

Whereas car makers orchestrate an army of contractors with highly integrated supply chain management systems, the R&D segment of the pharma industry does not yet engage in a holistic view of IT systems used in the conduct of their clinical trials, especially not in clinical supply chain management. To run a trial, up to 20 different software programmes are typically in use, with a majority of these either focused on or influencing the overall study logistics.

These software systems cannot be regarded as standalone any longer – data generated in one application has to be processed in others along the supply chain. With increased outsourcing, more players will be in the game, typically each with their own software.

For companies providing logistical services, the synchronised running of trials for numerous sponsors in parallel generates benefits for faster cycles and reduced total cost. On the other hand, the point-to-point integration is neither controllable nor economically viable.

What is the result? Surprisingly few clinical trials have a comprehensive and automated flow of information across their project. Yet consolidated information is vital to accurately run the demand-driven supply chain. Instead, paper trials, key individuals, endless spreadsheets and isolated databases still dominate the flow of fragmented information and slow down processes. Managing, collating and analysing this disparate information increases both costs and risks in the trial supply chain.

Application integration, or as we call it, eLogistics, is the only long-term solution for efficient clinical supply chain management – but it is a vision, not a buzzword. Currently, no one provider offers all of the software necessary for a complete supply chain for a clinical trial. Larger software players have acquired companies focused on certain steps in the supply chain, and offer integrated products as a suite. For example, database specialist Oracle offers a clinical trial supply chain solution set, and a step in the right direction. However, even these published suites do not cover the complete chain yet: neither are they applicable in the majority of currently running clinical trials. Multiple tasks in the supply chain are outsourced. Most GMP and courier contractors are using various selfdeployed IT systems along the supply chain, forcing the sponsor to adapt a type of ‘best in class’ approach.

So, how should the eLogistics concept be applied? We propose a five-step approach for all critical supply chain stages.

Step One – Determine the Scope and Clarify Demand

Identify which clinical trial supply services the project demands, and which systems are ideally used to optimise the supply chain from an IT perspective. At this point it is worth considering a non-exhaustive list of IT systems used for critical supply chain stages.

Planning
Production needs are challenging to forecast; numerous parameters such as patient enrolment expectations, number of investigational sites, countryspecific labelling, expiry dates, stratified randomisation and dropout rates of patients, as well as safety buffer stocks at sites and local depots. Sophisticated software, simulating the study conduct with a variance of input parameters provides numbers for overall and particular needs in terms of times and locations. As a result, the supply strategy is defined and the design of the supply chain is optimised, and in many cases significant savings on the expected costs can be reached.

Sourcing of Clinical Trial Material (CTM)
Various drugs are required, typically separated into investigational medicinal products (IMP) and comparator products, as well as other non-investigational products (NIMP). Most biopharmaceutical companies and contract manufacturing organisations are using proprietary software to manage IMP production. SAP, Oracle or JDA are typical supply chain management software suites developed for this purpose. Focused on the production of commercially available drugs, they can be applied for IMP as well. Non-investigational products are mostly provided by partners or bought on the market via wholesalers. Conditions to be taken into consideration for buying (central versus local suppliers, qualified suppliers), shipping and so on, needs experience and knowledge, often managed and maintained in databases The sourcing of ancillary supplies (medical and technical equipment, paper binders, and lab material) is often neglected, but are as essential as IMP sourcing. This is managed very differently from an IT perspective, from ‘by accident via Excel spreadsheet’ or purchase software packages to sophisticated warehouse management systems, with the final option being the most appropriate. Heterogeneous global compliance requirements need knowledge building, controlling and sharing information using databases.

Manufacturing of Material Customised for Trial Requirements
The packaging and labelling of all medicinal products includes primary and secondary packaging supported by packaging optimisation tools. Due to regulatory compliance requirements and language translation needs, dedicated software for label design, packaging design and labelling is frequently used.

Storage of CTM at Depots, Including Temperature Monitoring
CMOs such as Catalent or Aptuit are using high-end warehouse management systems, often adapted to the specific needs of the pharmaceutical industry. Such applications should cover all internal depot processes, from incoming goods to outbound shipment release. The storage of ancillary supplies requires slightly different handling compared to drugs, and is often assembled and stored in other, non temperature-controlled locations. As a result, different warehouse management systems may be used.

Distribution of CTM
This includes the distribution of IMP and medical devices to central or local depots as well as investigational sites, and even direct to patients, including temperature-sensitive items. Typically, each courier company has its own web-based tracking application and data transmission standards. The variety of national import and export regulations applicable to clinical trial supplies is tremendous. Accordingly, databases are in place to manage and track processes and country-specific information. But CROs and CMOs, as well as biopharmaceutical companies, have also implemented systems for distribution management, for instance interactive response technology (IRT) solutions such as RTSM from Perceptive Informatics, which offers such tracking. The import and export management of biological samples from analogue to IMP and NIMP or medical equipment is challenging in international trials, and mostly supported by database applications.

Site Management
This includes selection of patients and distribution of suitable products to investigational sites, including temperature monitoring. Again, IRT systems provide automated study medication management for sites, and trigger initial supply, re-supply, consignment orders, quarantine and recall when needed. For the distribution and tracking of lab samples to analytical laboratories, providing information on the status of biological samples is essential – and therefore supported by tracking applications, too. Regarding the management and distribution of lab results to investigators, systems for communication might be established, such as automatic fax or email result delivery, all trigged by a database.

Return of CTM
To complete drug accountability, returns of unused drugs from investigational sites must be managed appropriately. This requires complete ‘reverse logistics’, including evaluation of needs, courier management and tracking. Excel spreadsheets are frequently used for this task, but some IRT systems have started to support this part of the supply chain. Ancillary supplies also need sophisticated return management, as technical equipment, for instance, can be reused for other clinical trials. Warehouse management systems may cover such functionality.

Destruction or Recycling
Destroyed or recycled CTM needs to be tracked and accounted for; certificates of destruction have to be filed. Various IT applications are in place for these tasks as well.

Table 1 provides an example of a decision matrix for supply chain stage and IT system demand evaluation. Criteria of trial protocol complexity have to be defined up front and should consider typical supply chain parameters such as number and distribution of countries, sites and patients, packaging campaigns, visit schedules and dosing regimen, and so on. For each of the supply chain stages and complexities, a performance level of the required IT system has been assigned using the following grading system:

  1.  Normal spreadsheet sufficient
  2.  Isolated single IT solution appropriate
  3.  Highly integrated IT solution recommended
This will determine the trial-specific IT system requirements.


Step Two – Determine Business Critical Data Exchange Needs and Define Master System


Once all relevant trial systems/ applications have been identified, required data exchanges have to be defined. The guiding principle should be ‘as much as necessary, and as little as possible’. What data are captured in multiple systems? Define a master system – usually where data have been entered originally – and list the systems fed by it. Relevant cases might include the following:

  • Address data for investigational sites is required by almost four stages within the supply chain, from storage to return. More often than not, data is collected in each stage by different systems, disregarding the fact that most data is already known by the clinical monitoring teams. Feeding all logistics systems from a leading trial management system may save a significant amount of time, disburden sites and teams, and ensure consistent data throughout the supply chain. The site management application should be the master system
  • A batch of drugs is manufactured. All procedures are performed with the result that the batch is released for use. All related data (such as kit and batch numbers and expiry dates) are fed into storage and distribution systems, enabling them to generate the required shipments containing the released batch. No additional data input and QC steps are necessary. The manufacturing application should be the master system
  • The environmental monitoring system detects a temperature excursion in a certain area of the depot, and the medication stored in the area has to be quarantined. Transferring the information to distribution and site management systems avoids picking up drug product from a quarantined area. The distribution application (IRT) should be the master system

Step Three – Organise the Implementation of Data Exchange

Nearly all systems already have data export and import procedures in place. Responsible persons at the involved supply chain partners should convey directly the conditions for data transfer. An alerting process for transfers that are not running or have failed should always be in place. Table 1 may help start the assessment of needs versus efforts for integration. Be aware though that a data exchange programming effort may not be required for all systems – for instance, if it is only established for a single trial.

Step Four – Making the Supply Chain Visible

The IT systems in the supply chain vary in the way data are made visible to stakeholders. Frequently, there is no transparency of information; sometimes file exports are sent by email, or system specific web-based metrics are provided. This makes it a challenge to gain a complete overview of the status of the entire supply chain. In addition, apparently contradictory information can add confusion rather than clarity.

The complex but essential solution is to apply business intelligence. This of course is a project in its own right, which starts with intelligent downsizing to a justifiable amount of data required to control the supply chain, referred to as key performance indicators (KPIs).

Standard algorithms extract, transform and load data from the different logistics source systems into a kind of accumulator – a data warehouse. This type of warehouse concept supports a high performance analytics and metrics generation. The user interface is finally a matter of taste – many companies already have portals in place where metrics and other data can be displayed. If not, technologies today offer low cost solutions to visualise highly customised data.

Step Five: Standardised IT Integration in the Clinical Supply Chain

Applying the process described in steps one to four will result in an efficient and well controlled supply chain for a single clinical trial, but will be expensive when applied once only. The actual benefit lies in the economy of scale. Well-specified standards applied for multiple trials have a number of advantages. Most importantly, all players in the game have dedicated procedures they can rely on. When defined once but applied many times, standards can lead to a quick, safe and controllable setup of the supply chain with decreased costs.

Conclusion

Evolving mobile technologies, such as tablet PCs, an increasing number of Wi-Fi spots and other mobile standards will enable on-time access to data along the supply chain. This will even increase the pressure to optimise visualisation of supply chain data at every supply chain stage, from planning to the end of a project. It can be expected that over the next five to 10 years, many software solutions will become integrated along the supply chain. Data warehousing will become a gold standard for data collection and information insight. Tightly integrated systems as well as data and information exchange standards will be used as frequently as they should be.

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Dirk Machert joined PAREXEL International in February 2011 as Senior Manager, Technical Solutions for Clinical Logistics Service. Dirk has over 15 years of experience in project management of complex IT and organisational projects in multicultural environments, and in standardisation. Prior to joining PAREXEL, he spent four years as Senior Project Manager for Randomisation and Trial Supply Management Systems at Perceptive Informatics, providing customised IT systems to Big Pharma as well as small biotech companies. Before that, he held various operational and management positions at the German Standardisation Institute and its IT subsidiary.

Jens Mattuschka is Senior Director, Clinical Logistics Services Worldwide at PAREXEL International. He joined the clinical trial business in 1990 at Berlin University, Charité, and moved to the private sector in 1991 as a Database Manager for PAREXEL. Jens also participates as a trainer for Forum-Institut GmbH in Heidelberg, and teaches on the BSc in Clinical Research study programme at the University of Wales/PAREXEL Academy.
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Dirk Machert
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Jens Mattuschka
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