Project management

Our project managers have extensive experience that ranges from initial „first-in-human“ studies in Phase I through to large, international, multicentre studies. As your contact they will plan, coordinate and oversee your project and ensure that all the relevant information is made available at the right place and at the right time.

Procurement

We will source traditional packaging materials, tools as well as comparator drugs on your behalf. Thanks to our network of specialist partners, we are able to offer you supplementary services such as blinding by over-encapsulation and analytical tests.

Randomisation and unblinding

We are able to prepare randomisation lists for all types of study, i.e. simple or complex studies, placebo and/or competitor controlled, titration and crossover studies also employing double dummy methods. In addition, we will prepare emergency envelopes (code breakers) for the potential disclosure of individual patient medication should this prove necessary.

Identification and label printing

We will identify your trial drug, both with mono- or multilingual labels as well as booklets with any Unicode-encodable character set (including Western, Eastern European and Asian fonts). The printing and supply of labels and booklets is segregated strictly according to treatment groups, as per the specifications in the packaging plan.

Packaging

Our premises and machinery are FDA and Swissmedic audited. The validated, GMP-conforming processes are also suitable for supplies of clinical trial materials to Japan. When it comes to packaging, you can rely on our experience and expertise in primary and secondary packaging which also takes into account the special requirements that apply to clinical trial samples. What‘s more, we can fill blister packs with several products. We have at our disposal a large number of tools and lines for widely varying batch sizes and requirements. Our trained employees are able to package all manner of quantities and complexity levels for studies from Phase I through to Phase IV.

Quality control and EU approval

Your order-specific packaging instructions will be approved by our QA/QC department. Individual work steps will be accompanied by continual in-process checks and documented in their entirety. The orderspecific packaging inspection as well as the packaged intermediate and end products will be approved in conjunction with the issue of a corresponding GMP certificate by a qualified person. On request, we shall be pleased to guide the trial drug through the EU-Release process in conjunction with an experienced partner.

Storage and distribution

We will store your clinical trial trial materials with access restriction within the agreed temperature ranges, and attend to the deadlinecompliant worldwide distribution to study centres in conjunction with a qualified transport company. In the case of complex IVRS-supported studies, pick-label-pack order processing is also possible. We will be delighted to support you with batch tracing and the monitoring of expiry periods.

Return and disposal

We will process, account for and administer returns of clinical trial materials that have been sent back and, if requested with a qualified partner.