Clinical Services

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 had great success with companies that want smart, no hassle solution, because packaging is our passion. At Bellwyck, you will work closely with a dedicated project manager who will be your single point of contact from quote through project completion, providing excellent communication throughout the process. Bellwyck’s project managers are an integral part of an internal team of subject matter experts who will assist you with clinical packaging design, provide consultation, and develop a comprehensive quotation, avoiding surprises that could potentially delay your study or cost you more money.

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. Please browse our website for more details on specific service offerings and discover all of the ways in which Bellwyck might assist you in meeting your unique objectives.

Packaging Services

Bellwyck’s Project Management Team actively assists our clients in the design of clinical supplies and consults on packaging and distribution strategies which optimize utilization of finite drug supplies.

Smart Solutions are often offered which are outside requirements detailed in proposal requests. We apply our collective expertise and experience to ensure that our clients receive clinical materials which are more than ‘fit for purpose’ – we aim to deliver well-conceived packaging solutions, on time, with excellent communication and project management a constant throughout the process.

Regardless of the study phase, the magnitude of the trial, dosage forms being studied or trial design, Bellwyck has the experience to ensure the successful execution of your clinical packaging project.

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.

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.

Protecting the integrity of your clinical study cold chain

   

Over $260 billion of annual biopharma sales are dependent on cold chain logistics to ensure product efficacy, according to the Department of Commerce, and they further state that logistics spending is currently more than $10 billion and is expected to grow to $13 billion by 2019 within this industry. With billions of dollars at stake, maintaining temperature controls across the entire supply chain for clinical trial materials from point of manufacture, through packaging, labeling, storage, and distribution to investigator sites is a primary objective and plays a critical role in bringing new drugs to market. Any weakness in the chain can compromise integrity, delay shipments, result in large financial losses, and raise the costs of clinical trials.

Working with a clinical supplies partner that understands the industry and has the experience to guide its customers through the process is critical in ensuring cold chain reliability. Bellwyck Pharma Services has nearly a quarter century of clinical trial experience behind its name. The company has significant expertise in the field of cold chain logistics and, depending on specific product requirements, can offer various solutions. Bellwyck offers controlled room temperature, refrigerated (2° C to 8° C), and frozen(-20° C and -70° C) GMP compliant storage solutions for clinical trial materials.

Controlling storage and transport conditions is critical. There are situations that require the product be outside of the refrigerator or freezer for short periods of time, such as for packaging and labeling based on product stability. Manufacturers or trial sponsors will communicate excursion limits to account for this. Bellwyck understands that temperature excursions outside the specified range can have a substantial negative impact on a clinical trial study, impacting the quality, efficacy and safety of products. Therefore, times in and out of storage are closely monitored and documented. For highly sensitive materials, those with low excursion times, and those with limited stability data, Bellwyck can provide cold processing and packaging.

Bellwyck also ships product to depots or investigators following manufacturer’s requirements to avoid exceeding excursion limits. There are no cookie cutter solutions, and Bellwyck works closely with each manufacturer or clinical trial sponsor to provide an optimal solution, while taking into account environmental conditions, seasonal changes, and geographic locations that can impact the shipping container’s ability to maintain the required temperature range. Bellwyck has facilities in the U.S. and Canada, which gives them the ability to perform these labeling, storage and distribution services in the country in closer proximity to the bulk manufacture location or the clinical trial sites By having locations in both U.S. and Canada they can ship domestically overnight directly to investigators without border crossings and customs clearance.

Navigating the regulatory requirements for scheduled drugs

Ensuring that your clinical trial goes smoothly is a primary priority for Bellwyck Pharma Services, particularly when controlled substances are involved. A large part of the complex supply chain support required for clinical trials using scheduled drugs is understanding and having the skill to navigate the regulations surrounding them. Bellwyck’s experience with DEA Schedule II-V controlled substances and Class I and II chemicals will ensure your product’s integrity and security remain intact. It is critical that you partner with a reliable supply chain solutions provider, such as Bellwyck, that will ensure compliance in this strict regulatory environment.

Security and storage

Bellwyck’s Ohio location is registered with the Drug Enforcement Agency (DEA) to provide labeling, kitting, distribution, and secure storage for schedule II-IV drugs. With a 36-pallet, secure and video monitored vault, Bellwyck has the capacity to handle not only your secondary packaging needs, but also returned drugs slated for destruction. Bellwyck’s Burlington, Ontario facility is similarly licensed by Health Canada’s Office of Controlled Substances and has Level 11 capabilities.

Bellwyck closely follows cGMP practices and US/Canadian regulations (including 21 CFR 1300-1399) for controlled substances. This includes having a secure facility and vault; having an auxiliary gas powered generator in the event of power outage; having continuous monitoring in the vault, surrounding areas, and packaging areas; requiring at least two authorized employees be present when accessing the vault or packaging area with controlled substances; and requiring employee background checks, drug testing, and extensive training. Bellwyck also offers controlled room temperature, refrigerated (2° C to 8° C), and frozen (-20° C and -70° C) cGMP compliant storage solutions for clinical trial materials.

Labeling, kitting, and distribution

With experience in labeling and kitting all dosage forms, including bottles, blister packs, and syringes, Bellwyck can ensure a smooth secondary packaging and logistics experience. Clinical labeling that conveys precise and succinct instructions to your studies’ participants and meets regulatory requirements is critically important. Bellwyck designs and prints single and multi-panel, randomized, multi-language labels using its fully validated and cGMP compliant ClinPro® clinical labeling system, so you can rest assured that your labels will meet not only our stringent quality standards but yours as well. Expedited shipments are no problem. Bellwyck can assist in ensuring all the required documentation is in place in order to ship schedule II-V controlled substances domestic overnight when required.

Importing

As drug manufacturing has become global, often drugs must be imported for clinical trials. To accommodate these customers, Bellwyck also holds a DEA importation registration for its Ohio facility and has the ability to import product into the Ontario, Canada facility, giving pharmaceutical and biotech companies greater flexibility to meet their goals.Importing drugs with bovine and/or porcine components, such as gelatin capsules, provide another layer of complication. Fortunately, Bellwyck has experience working with the USDA to secure permits for importation.

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.

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