Laying the foundations for a compliant and secure service

Laying the foundations for a compliant and secure service

Comprehensive report supports launch of compliant new service to drive business growth

Business drivers

Established over 35 years ago, this life sciences logistics specialist provides pharmaceutical professionals, researchers and scientists with industry-leading supply chain solutions. With an extensive network of global offices, the company manages temperature controlled transport to ensure the legal and safe shipping for the biotechnology, pharmaceutical and clinical trial sectors.

The client was looking to expand their current clinical trial logistics service offerings to include Direct to Patient (DTP) and Direct from Patient (DFP) shipments.

DTP shipments typically involve delivering and collecting drugs or other clinical trial materials to and from clinical trial subject homes on behalf of its customers, such as clinical trial sponsors, Contract Research Organisations (CROs), Contract Manufacturing Organisations (CMOs) or Central Labs.

In order to successfully offer this service, this leader in life sciences logistics needed to ensure all relevant data protection, operating procedures and clinical trial regulations in place met all the strict compliance requirements. They also needed to provide their clients with clear evidence that they had well-defined, compliant and auditable processes in place, based on secure systems that satisfied regulatory requirements to minimise data risk.

Key requirements

The business recognised the need to define and document their current DTP, and identify any risks or gaps to compliantly operate this service and grow their operations moving forward.

Metataxis was engaged to investigate and map the DTP already processes in place, looking at how patient information was managed, how processes were documented, how procedures were followed and identify any areas of information risk.

The Metataxis approach

To understand the full picture, Metataxis worked closely with business representatives, conducting interviews, and performing valuable desk research. By speaking with colleagues from all areas of the DTP process, we were able to use their feedback to establish a full review and mapping of existing DTP processes.

We reviewed all relevant policy and process documentation, as well as existing data protection artefacts such as the ROPA, DPIAs, and their current data Retention and Disposal Schedule.

Using our knowledge of Data Protection legislation, Good Distribution Practices, industry best practice and client expectations, we went on to document their future state requirements. We then used these requirements to create a process map which set out the ideal DTP process to be deployed across the business.

Finally, the Metataxis team undertook a gap and risk analysis, identifying any areas that were non-compliant or required additional work, and provided recommendations to increase compliance and reduce risk.

Business benefits

Metataxis delivered a comprehensive report covering detailed “as-is” and “to-be” process maps of their DTP services. It also included a gap and risk analysis, information on processes, documentation, governance, and compliance, as well as training and awareness, technology and systems.

We then went on to make recommendations for the future state of DTP for this logistics supplier and identify changes that needed to be implemented to help them meet their future DTP goals.

We proposed a phased plan to enable compliant DTP deliveries moving forward.

Armed with clear plan that meets appropriate standards, key regulations and follows best practice and procedures to protect and manage data in a compliant and secure way, this logistics business now has the foundations to develop more advanced processes and can confidently launch a robust product offering, that will support the future growth of this valued DTP service.

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