BELLWYCK has been in the business of clinical supplies packaging for over 20 years. The industry has changed substantially over this period; from distribution to study sites of small blocks of material to dynamic randomization/distribution managed by IVRS systems; from unilingual, country-specific packaging to global supplies strategies employing multi-lingual, expanded content booklet labels; and the rise of the biopharmaceutical industry, with its emphasis on parenteral drug administration and controlled-temperature supply chains.

Throughout these 20 years of change, BELLWYCK’s packaging services have been delivered with first-class project management and consulting support. We have assisted our clients stay on top of industry best-practices, remain compliant with regulatory issues (in multiple jurisdictions), utilize cost-efficient packaging strategies which facilitate patient and protocol compliance, and launch their clinical studies on time.

PACKAGING SERVICES:

Returns and Reconciliation

Clinical supplies can be returned to BELLWYCK’s premises for reconciliation and accountability. We can manage destruction activities, organizing materials into appropriate waste-streams and conclude the process by issuing a Certificate of Destruction.

Compassionate Use and Special Access Program

BELLWYCK has experience of administering many Compassionate Release and Special Access Programs. Individual Programs differ tremendously as they respond to unique requirements of the patient group, sponsor or regulatory body and BELLWYCK customizes its processes accordingly.

Out-sourcing this activity to BELLWYCK is the perfect solution to the problem of managing an activity which is often characterized by an unpredictable frequency and volume of requests.

Procurement

BELLWYCK has accounts with pharmaceutical wholesalers and is able to procure comparators, rescue medications, concomitant medications or ancillary supplies on our clients’ behalf.

LABELS:

Clinical labels are critically important in ensuring regulatory/patient compliance and conveying precise but succinct instructions to study participants.

BELLWYCK employs its in-house ClinPro® fully validated clinical labeling system, detailed SOPs and comprehensive employee training to ensure cGMP requirements are met. ClinPro® software supports all trial designs and assists in the critical control of randomization code generation (or importation), printing, checking and archiving processes.

Booklet labels incorporating multiple languages are also available through BELLWYCK with our Project Managers facilitating translations, regulatory approvals and proofing. Printing and assembly of booklet labels is an out-sourced activity but the critical step of printing unique randomized data fields is managed in-house using ClinPro®.

LOGISTICS:

Premises in both the US and Canada allow domestic, overnight shipments to be made to the majority of North American investigators. We establish depots in strategic locations to facilitate global distribution, under the oversight of our experienced Project Management Team.

Our GMP compliant storage capacity includes room temperature, refrigerated, frozen, and ultra-frozen conditions – plus the ability to store controlled substances.

BELLWYCK has significant expertise in the field of cold chain logistics and multiple solutions are available depending on your specific project requirements. 

OTHER SERVICES:

Returns and Reconciliation

Clinical supplies can be returned to BELLWYCK’s premises for reconciliation and accountability. We can manage destruction activities, organizing materials into appropriate waste-streams and conclude the process by issuing a Certificate of Destruction.

Compassionate Use and Special Access Program

BELLWYCK has experience of administering many Compassionate Release and Special Access Programs. Individual Programs differ tremendously as they respond to unique requirements of the patient group, sponsor or regulatory body and BELLWYCK customizes its processes accordingly.

Out-sourcing this activity to BELLWYCK is the perfect solution to the problem of managing an activity which is often characterized by an unpredictable frequency and volume of requests.

Procurement

BELLWYCK has accounts with pharmaceutical wholesalers and is able to procure comparators, rescue medications, concomitant medications or ancillary supplies on our clients’ behalf.