Sply

+4560198464

Fruebjergvej 3, 2100 Copenhagen, Denmark

© 2017 - 2020
Sply ApS: CVR-nr: 38486160 / Sply Tech ApS: CVR-nr: 38722662

Clinical Drug Supply

Grow Your Internal Supply Team

Management of manufacturing, packaging, labeling, distribution, and return of supplies for clinical trials

 

Examples of Our Expertise in Clinical Supply Management

Sply is composed of a group of project managers holding an MSc within Pharmacy and Supply Chain. Clinical trial timelines are essential to our sponsor customers and, therefore, of the highest priority to Sply. We are continuously working to optimize our procedures and method of working with a goal to increase the quality of our work and the success of the trial we are involved in. As a small group, we consider ourselves a fast, agile, and dedicated partner.

Billede af Walter Otto

CMO/CDMO Management

Billede af Helloquence

Operational Clinical Supply Coordination

Computer Kontorarbejde

Randomization and Trial Supply Management Systems (IRT/IWRS)

Outsourcing of packaging, storage and distribution services

  • CMO/CDMO incl third party depot network selection and oversight

  • Specification of Primary and Secondary packaging operations

  • Batch record reviews

  • Coordination of comparator and material sourcing

Management of all aspects of planning. manufacturing, packaging, labeling, distribution and retun of supplies

  • Act as an independent un-blinded supply manager in your trial.

  • Creation of robust project plans and track of study progress

  • Inventory and distribution management​

  • Writing the packaging/labeling section of the clinical trial protocol

  • Writing of IMP processes aligned with clinical operations

  • Drug demand forecasting considering site activation, enrolment projections, and project constraints.

  • Patient kit and label design

  • Kit list generation

  • Returns and reconciliation

Management of the IRT/IWRS System

  • Experienced with many leading IRT/IWRS systems

  • User requirement specification and integration to third-party systems e.g. EDC 

  • Master test plans and test reporting

  • User Acceptance testing 

  • Change management

  • Site management (optimal supply plan setting, inventory control, etc.)

 

Consultants

Our experienced Drug Supply Managers are providing excellent client service as an integral part of your team

Antony Pham

(MSc Pharmacy)

Consultant

Jonas Dyndegaard

(MSc Supply Chain Management)

Consultant

Peter Kock

(MSc Pharmacy)

Consultant