Pinesoft Partnership Marken Clinical Trials Logistics

Logistics for clinical trials

Marken supports the premium logistics of Pharmaceutical, Biotechnology and clinical service companies. How can it respond to its clients’ evolving needs?

With over 400 people in 23 offices spanning the world, Marken manage the collection and transport of specimens, and the distribution of clinical trial supplies through customised programmes to ship items globally and deliver locally to investigator sites or directly to patients.

A clinical trial will have precise requirements and often strict environmental conditions under which items must be carried with detailed reports required for later audit by authorities such as the FDA. The items to be carried have often been produced  at great cost and specifically for one trial so the value of each item that Marken carries can amount to thousands or even tens of thousands of dollars.

To Marken they are priceless and Marken logistics consultants work closely with the pharma and their Clinical Research Organisation to set up an appropriate distribution plan and then adjust that plan according to any changes in conditions.

The needs for flexibility alongside stringent controls puts pressure on the IS function.

Marken has been developing new systems to meet its targets for service innovation. CTO Simon Kirk is an advocate of Agile development, promoting the evolving needs of the business over predefined specifications.  He comments “A question to ask senior management is “What’s the minimum level of plan that you can live with?””. Within  Clinical Trial logistics, the high cost of producing the treatments and the potential value of the trial results mean that plans are usually amended during the course of each.

Therefore, Marken’s business involves frequent change and they use the team at Pinesoft to develop software with  functionality that is prioritised according to the business requirements as they arise. For example, costs of clinical trials are increasingly scrutinised and, at short notice, in order to support business development with a new client pitch, new software may be required in order to demonstrates operational efficiencies for a new account.

Pharmas work with integrators like DHL and UPS as well as specialist providers whose systems must link through seamlessly  in order to provide a single point for tracking as well as operational efficiencies such as consolidated invoicing.

Clients also require integration with their own systems:

  • enter a booking on their system and have a label passed back from Marken’s system
  • Use a Clinical Research Organisation to manage a trial but receive invoices directly
  • View a POD note online

Marken offer unique services so the only way to manage these are with custom-developed software systems. Developing these by using an Agile approach gives the flexibility and the performance to meet the requirements of all stakeholders.