Clinical Supply Management

What is Clinical Supply Management?

Clinical supply management is the act of ensuring clinical trials are fully supplied from first patient-in date until trial completion while complying with regulations across the globe. Based on the clinical study design, clinical supply managers need to structure a supply strategy that takes into account factors such as stretching limited drug supply, timing, dosing schedules, number of sites, temperature monitoring, comparator drugs, ancillary supplies, serialization, returns and destruction. It requires a strong understanding of different regulatory requirements and depot management, and usually involves different packaging, labeling, and distribution technologies to ensure clinical supplies are manufactured, prepared, shipped and delivered at the temperatures and in the environments required.

Read on below to learn best practices from our white papers and articles, in addition to tips and resources from Sherpa professionals and industry thought leaders.

Shortcuts:

Clinical Supply Strategy

Clinical Labeling & Packaging

Clinical Supply & Regulatory Guidelines

Cold-Chain Logistics

Direct-To-Patient (DTP)

The Qualified Person (QP) Role

Brexit

Just-In-Time Clinical Supplies

How Sherpa Can Help You with Your Clinical Supply Management

Clinical Supplies Community

 

Clinical Supply Strategy

Back to top

6 Strategies to Stretch your Limited Drug Supply for Clinical Studies
Bringing a new drug to market can be a heavy financial burden on any pharmaceutical company. It has become even more burdensome over the last several years as the industry pushes the boundaries of innovation. This is because newer, often more-complex therapies not only increase risk in drug development but also drive costs even higher.

That is why it is important to have a clinical packaging strategy that can successfully manage the supply of your expensive drug product throughout the duration of clinical testing. To do this, sponsor companies must balance control of the drug supply with control of shipping costs. Achieving this requires maximizing the amount of drug available for distribution while minimizing overages across clinical trial sites.

The following six strategies can be used to find balance with the support of a trusted clinical packager:

  1. Employ a Drug-Sparing Strategy
  2. Ensure Rigorous Patient Screening and User-Friendly Packaging
  3. Identify Accommodating Kit Design
  4. Centralize Clinical Supply Storage
  5. Select Countries with Flexibility in Mind
  6. Use Just-in-Time Strategies

Read the full white paper.

Back to top

Clinical Labeling & Packaging

Back to top

What your Clinical Study Design Reveals About Your Clinical Packaging Needs
To ensure the timely delivery of the necessary supplies, a sponsor must have a strong clinical packaging strategy that takes into account the most important details of its clinical study design. These details encompass the intricacies of logistics, distribution, staffing, patient recruitment, patient adherence to therapy, and regulatory compliance. The goal is to be able to respond appropriately to any surprises or issues that could not only jeopardize your study but also potentially delay your product’s development and launch.

With the price tag of bringing a drug to market recently estimated at nearly $2.6 billion, getting your clinical supply strategy right can be the difference between bankruptcy and survival for some companies.

The key details needed to develop your clinical packaging strategy include:

  • Study size and enrollment rate
  • Timeline and duration of clinical study
  • Dosing configuration
  • Drug storage temperature
  • Label and package considerations

Read the full white paper.

Back to top

Key Considerations for Companies Outsourcing Their Clinical Packaging Needs
Outsourcing is a key consideration in clinical packaging and distribution for companies across the board. Outsourcing is a valuable strategy for companies of all sizes and capabilities, but it should be entered into for reasons specific to a company’s requirements. This article gives tips in selecting a supplier that meets the most important factors that the sponsor requires.

It is important to select a supplier that meets the most important factors that the sponsor requires. For instance, for a large pharmaceutical company, outsourcing due to limited internal capacity may be a driver. For smaller companies, and especially for virtual companies, outsourcing is necessary to fill gaps in operational capabilities and core competencies.

There are several objective factors that should be considered in narrowing the selection. Some of these considerations are:

  • Years of experience
  • Financial stability
  • Range of services offered that are in the scope of the project
  • Location of facilities
  • Track record and reputation
  • Size of company
  • Compliance history

Some of the subjective factors regarding cultural connections that might be considered are:

  • Responsiveness to communication
  • Transparency
  • Following direction
  • Cultural fit between companies
  • Customer service
  • Trust and rapport

Read the full article.

Back to top

How to Navigate Clinical Supply for Breakthrough-Designated Drugs – Portola Pharmaceuticals’ Andexanet Alfa
Breakthrough-designated drugs add significant pressure to a pharmaceutical company’s planned clinical study, including accelerated pace and added stress on the clinical supply chain. This case study highlights the clinical supply challenges that come with the breakthrough-therapy designation, and offers a look at possible solutions.

The Situation:
Andexanet Alfa’s breakthrough designation added significant pressures to Portola’s planned clinical studies, accelerating their pace and putting added stresses on the clinical supply chain. This necessitated speedy changes in logistics and clinical supply.  Running multiple trials in several countries, with finite drug supplies, complicated matters even further.

Clinical Supply Management Solutions:
Sherpa Clinical Packaging’s built-in flexibility, creative problem-solving, and speed were instrumental in keeping Portola’s multiple clinical studies on track. Sherpa was responsive in the face of ever-changing clinical supply requirements, a common issue with trials for Breakthrough drugs.

As Portola was given rolling recommendations from the FDA on how to proceed, their clinical supply needs changed at a moment’s notice. Sherpa’s responsive project management, in-house label printing capabilities and rapid turnaround times on production and batch records allowed Portola to meet expedited timelines for all Andexanet Alfa studies.

The strength of Sherpa’s global depot network ensured that all of Portola’s international clinical sites had the necessary supplies as they were needed.

Results:
Sherpa and Portola created a trusted partnership and collaborated closely to keep Andexanet Alfa studies on track. Creative packaging, responsive and flexible project management and operational systems and a strong global depot network have kept disruptions to a minimum. All trials are running optimally, and Andexanet Alfa is poised for regulatory approval in the U.S. and E.U.

Read the full case study.

Back to top

Stay Cool: Clinical Trials Materials (CTM) Management Services
As clinical trials become more global in nature, clinical trial materials (CTM) are becoming more complex to manage. As biologics-based products become more prevalent, temperature control is key, and pharma companies require logistics partners with well-developed cold-chain capabilities. In this article, Mark Paiz, President of Sherpa Clinical Packaging, explains how a specialist in CTM management services can provide the support pharmaceuticals companies require, particularly in the area of temperature control.

Read the full article.

Back to top

EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market
Maintaining product quality and integrity is increasingly difficult in today’s industry. In recent years, there has been explosive growth in the biotech and advanced therapeutics markets. This makes the need to maintain appropriate temperature and environmental conditions for these sensitive
drugs a major focus. Should a batch of drugs deviate from its required temperature range during storage and transport, it may not be able to provide its intended therapeutic effect. This risk becomes even higher if a drug is temperature sensitive and has to travel through changing or extreme climates.

Recent EU GDP Changes you Need to Know
The expanded oversight from the updated EU GDP guidelines brings nearly all finished pharmaceutical products under these temperature control
requirements during transit.3 With this in mind, it is critical for the industry to understand and follow them. Although sponsor companies should be familiar with the guidance in its entirety, particular focus should be on these three areas:

  1. Quality systems
  2. Equipment
  3. Computerized systems

Read the full white paper.

Back to top

Clinical Supply & Regulatory Guidelines

What’s the Importance of Annex 13 Labeling Requirements?

Can you imagine working for months to ensure your clinical supply strategy is in place for your European studies, only to have them be delayed because labeling requirements were out of compliance, and the QP or the site(s) rejected the materials you wanted to use in a trial?

You will understand:

  • The minimal labeling requirements when primary and secondary packages are to be together versus separated.
  • Why meeting Annex 13 labeling requirements is crucial to starting your clinical trial on time.
  • The label text required when managing labels for small units such as ampoules.

The purpose of this guide is to walk US-based clinical supply professionals through the labeling requirements laid out in Annex 13 of the EU GMP guidelines. This annex details guidance for Investigational Medicinal Products (IMPs), and this handbook will focus only on those Articles applicable to labeling requirements (Articles 26 to 33). For US pharmaceutical companies planning clinical trials in Europe, it is critical to comply with these labeling requirements so as not to experience any delays.

Download Your Annex 13 Booklet Here.

Back to top

Cold-Chain Logistics

Back to top

OrthoTrophix’ Intra-Patient Randomization Design Supported by Advanced Cold-Chain Packaging
Osteoarthritis affects around 30 million Americans, causing pain and severe disability. Unfortunately, there are few treatments. Many rely on over-the-counter analgesics to manage their pain. Some ultimately opt for joint replacement surgery. To better help patients, OrthoTrophix is developing a peptide drug designed to regenerate cartilage. The company hopes this approach will restore function.

Challenges:
OrthoTrophix conducted a two-part, phase 2 trial to demonstrate the drug’s safety and efficacy. This required a complex clinical study design that relied on advanced clinical supply logistics. Because the drug for this trial was a frozen liquid, storage, packaging and delivery were quite challenging. In addition, patients in the trial received the active drug in one knee and a placebo in the other. The study required that each patient receive four injections, one week apart. The packaging had to make it easy for physicians to inject the correct knee with the correct agent.

See the solutions & results to these challenges in the full case study.

Back to top

Stay Cool: Clinical Trials Materials (CTM) Management Services
As clinical trials become more global in nature, clinical trial materials (CTM) are becoming more complex to manage. As biologics-based products become more prevalent, temperature control is key, and pharma companies require logistics partners with well-developed cold-chain capabilities. In this article, Mark Paiz, President of Sherpa Clinical Packaging, explains how a specialist in CTM management services can provide the support pharmaceuticals companies require, particularly in the area of temperature control.

Read the full article.

Back to top

Direct-To-Patient (DTP)

Back to top

Direct-To-Patient (DTP) Clinical Supply Cheat Sheet

The word Direct-To-Patient is being thrown around a lot and not many people know what it is. This blog with answer questions like “What is the definition of Direct-To-Patient?”, “What should I do if I’m considering Direct-To-Patient for my clinical trial?”, and “What are the regulatory issues that need to be planned for if a Direct-To-Patient study is going to move forward?”

At the 2018 Sherpa Summer Seminar we had an expert panel answer these questions and with great insight on how Direct-To-Patient is changing the world of clinical trials.

See the full Direct-To-Patient article.

Back to top

The Qualified Person (QP) Role

Back to top

The EU Qualified Person and Clinical Supplies
The European Qualified Person (QP) role was established originally via a Directive published in 1975. This required all manufacturing sites (initially only those dealing with commercial products) to have the services of at least one QP to act in a legal capacity to certify batches for release. Time is allowed via the EU process to incorporate EU Directives into national law so for many countries, the legislation wasn’t in place until 1977 or later. As this was new legislation, people already carrying out this role were allowed to become QPs via a transitional process. For many years now, anyone new wanting to become a QP has to go through the so called “permanent” provisions route. The requirement for a QP to certify batches for Investigational Medicinal Products (IMPs) was introduced via another EU Directive published in 2001. It should be noted that in both cases, the legislation was introduced via a “Directive” which means this has to be incorporated into national law. This allows for some differences to emerge as the Directive is reviewed against existing laws so unfortunately, the system is not exactly the same across all EU countries.

Sue Mann, Managing Director and QP Consultant of Sue Mann Consultancy, and 2017 Sherpa Summer Seminar speaker, answers some common QP questions, including:

  • Is the QP role a batch releasing role?
  • Can I contact an EU QP and ask them to act for me as a QP in the EU?
  • Does the QP role only involve batch certification?
  • Where testing and packaging are concerned, is there only ever one QP involved?
  • What are the differences between QP Certification and Release?
  • I’m confused on what Annex 16 entails. Can you please explain it?
  • For early phase (Ph 1/2) trials, what are the requirements regarding the need for “Leading” Stability data? And if there are requirements, such as 6 months in front of actual IMP, then are there any leniencies shown (e.g., for orphan drugs)?

See Sue’s answers, and the full article.

Back to top

10 Things to Remember about the QP Role and Process
The QP process is a necessary process that every sponsor company wishing to undertake trials in, or move product through the European Union must undergo. When faced with this process, many companies are unsure as to what to expect. Here are the top ten things that sponsor companies should know about the QP Process.

  1. DO know that the role is embedded in the whole process and is not “just” a release function at the end.
  2. DO know that this also includes the API or DS that is relevant for the batch in question.
  3. DO know that the QP process differs from what happens in the US.
  4. DO control and monitor shipment of products that are stored at ambient temperature.
  5. DO know all your sites that have to be certified.
  6. DO understand your trial’s back up or escape medications, etc.
  7. DO know that there may be more than 1 QP involved in the whole process for obtaining CT supplies.
  8. DO know that in the EU, it is common practice to add the “use by” or “retest date” on the label on the CT packs.
  9. DO know that recent changes in the EU GMPs, which focus on the prevention of cross contamination when working in multi- product facilities, also apply to those facilities where CT products are manufactured and packed.
  10. DO know that after QP certification, the QP should still be involved (or at minimum informed), if any updates to the labelling are required (e.g. shelf life extensions), any materials need to be moved to another site and of course any quality issues that may arise.

Read the full article.

Back to top

Top Clinical Supply QP Questions Asked at the 2017 Sherpa Summer Seminar
Any sponsor company planning clinical studies in Europe needs to be prepared for the QP process. There are a lot of questions surrounding the QP process, which was clear by the tremendous response to the QP expert panel at the 2017 Sherpa Summer Seminar.

Three of the top questions surrounding QP, were:

  • Under what circumstances can a sponsor company provide a QP with an audit from a different client, different drug product. Does it really have to be a de novo audit for each individual QP process?
  • In a situation where a sponsor didn’t know they would be going to Europe – they’re in early clinical trials, the materials have been manufactured, the US GMP audits have been done, but the QP audit has not been done – how does a QP address this?
  • My first IMPD was filed and reviewed in European countries, and the first few batches were released according to those specifications and review process. We’ve now revised our specifications because we have learned more, and now have IMPD 2 that is being submitted for approval to all the participating countries. What do I have to do with the batches released under IMPD version 1?

See the expert panel’s answers, and the full article.

Back to top

The QP Role and Annex 16, Stability Data, and Audit Reports
Additional questions regarding QP at the 2017 Sherpa Summer Seminar:

  • After Annex 16 came out, our QP asked us for audit reports from our vendors that we qualified. We pushed back that we can give them the audit certificate or statement, but not the report due to confidentiality agreements. What is your advice on navigating the Annex 16 requirement when it comes to the QP process?
  • How much does a QP’s involvement continue after release? Is there QP follow-up related to stability data? If there are protocol revisions, is the QP involved then?
  • We often receive a request a few weeks before the first patient is expected in, asking for a QP release which sounds quite unreasonable. When is a good time to involve a QP and make sure you’re meeting your timelines?
  • Is leading stability data required for QP release? If we have leading data from either a platform product that’s very similar but not necessarily the same process can this be used or is leading stability data required from the exact same process? How much lead time is required?

QP Process Cheat Sheet

The QP process is a necessary process that every sponsor company wishing to undertake trials in, or move product through the European Union must undergo. When faced with this process, many companies are unsure as to what to expect.

Our QP Process Cheat Sheet lists ten things that sponsor companies should know about the QP Process, such as:

  • The  QP role is embedded in the whole process and is not “just” a release function at the end. The QP needs to be satisfied regarding all aspects of the batch in question – what went into it and how/where it was made/tested/packed. Sponsor companies should prepare for questions regarding this. Download the cheat sheet for a list of standard documents that a QP could ask for.
  • In the EU, it is common practice to add the “use by” or “retest date” on the label on the CT packs. At present, where used, this would typically be on the secondary package (e.g. wallet, carton) but please note that when the CT Regulation comes into effect, this labeling requirement will also apply to the primary packaging as well.
  • Recent changes in the EU GMPs, which focus on the prevention of cross contamination when working in multi- product facilities, also apply to those facilities where CT products are manufactured and packed.

See the expert panel’s answers, and download the QP Cheat Sheet.

Back to top

The QP Process Quiz for Clinical Supply Professionals
Test your Qualified Person (QP) knowledge with questions like:

  1. How will Brexit affect clinical supply?
  2. Is there an active Mutual Recognition Agreement (MRA) between the EU and USA?
  3. If a site in the US performs packaging and labelling of an investigational medicinal product then ships this product into the EU for a clinical trial, will someone from the EU receiving company want to audit the US packaging site?
  4. Can clinical trials materials be shipped to an investigator site before QP certification has been given?
  5. Does the QP routinely review all documentation supporting a batch before certifying it?
  6. What is meant by the term “eligible” to act as a QP?
  7. Does a QP need to be a full time, permanent employee at a site?
  8. What is the difference between the European Union (EU) and European Economic Area (EEA)?

Take the quiz and check your answers.

Back to top

Brexit

Back to top

Brexit Causing Uncertainty for Clinical Supply
The UK has been an uneasy member of the European Union for many years and it came as no total surprise when on the 23rd of June 2016 the UK population voted to step out of the European Union and Brexit was born. John Shillingford, PhD, Independent Consultant, wrote about some concerns that sponsor companies should consider as they consider holding clinical trials in the EU or the UK in 2019 (when Brexit is scheduled to be official).

John covers topics including:

  • European Medicines Agency (EMA) relocation will cause slowdown in the global clinical research community
  • Does Brexit mean exit from the 2019 one portal clinical trial assessment and approval system?
  • Brexit’s effects on the role of the qualified person (QP)
  • A fork in the road lies ahead: UK or the EU?
  • What’s next?

Read John’s full article.

Back to top

For the Clinical Supply Field – Some Brexit Answers, More Questions
It is no secret that Brexit will have a large impact on the pharmaceutical industry come March 2019 when the UK exits the EU. Since the UK voted to leave the EU on June 23, 2016, questions have been raised on the logistics of the transition, and how companies planning clinical trials in the EU will be affected. Where will the EMA be relocated to? How will the QP process be affected?

In the last quarter of 2017, more news regarding Brexit has been released, providing some answers for the clinical supply field. John Shillingford, 2017 Sherpa Summer Seminar speaker and independent consultant discusses these new developments and clarifies what questions we still need answers to. Spoiler alert: there’s a lot left unanswered.

Some critical remaining issues are:

  1. The maintenance of scientific assessment and advice services
  2. The maintenance of New Product Assessment and approvals
  3. Oversight and maintenance of Pharmacovigilance systems in the EU and EEA countries with the UK having left
  4. Oversight of the Qualified Person (QP) system for drug importation of Investigational Medicines and Drug Finished Product in the EU and EEA after the UK’s exit.

Read the full article.

Back to top

Top Brexit Questions Asked by Clinical Supply Professionals at the 2017 Sherpa Summer Seminar
Any sponsor company planning clinical studies in Europe needs to be prepared for the QP process. There are a lot of questions surrounding the QP process, which was clear by the tremendous response to the QP expert panel at the 2017 Sherpa Summer Seminar.

Three of the top questions surrounding QP, were:

  • Under what circumstances can a sponsor company provide a QP with an audit from a different client, different drug product. Does it really have to be a de novo audit for each individual QP process?
  • In a situation where a sponsor didn’t know they would be going to Europe – they’re in early clinical trials, the materials have been manufactured, the US GMP audits have been done, but the QP audit has not been done – how does a QP address this?
  • My first IMPD was filed and reviewed in European countries, and the first few batches were released according to those specifications and review process. We’ve now revised our specifications because we have learned more, and now have IMPD 2 that is being submitted for approval to all the participating countries. What do I have to do with the batches released under IMPD version 1?

See the expert panel’s answers, and the full article.

Back to top

Just-In-Time Clinical Supplies

Just-in-Time Packaging and Shipping Supports Multiple, Complex Clinical Trials
Selecting appropriate clinical packaging and shipping strategies can be the difference between an efficient clinical supply chain, or an expensive fiasco. This case study details how Sherpa Clinical Packaging partnered with South Bay Therapeutics* to craft the best clinical supply management strategies for their multiple, complex clinical trials.

South Bay Therapeutics, a Southern California pharmaceutical business, was conducting as many as five studies simultaneously for the same drug, which led to supply challenges. South Bay Therapeutics’ drug product is a viscous injectable delivered in vials or pre-filled syringes. Because the inventory needs for each site changed frequently, packages had to be reworked often to meet new clinical demands, a time-consuming and costly process.

In addition, some sites handled multiple studies with differing protocols. Each package had to be labeled clearly, to avoid errors, and delivered quickly to the appropriate site.

JIT helped South Bay Therapeutics* to:

  • Streamline their clinical supply chain
  • Efficiently manage multiple trials
  • Optimize limited drug supply

Read the full case study.

Back to top

How Sherpa Can Help You with Your Clinical Supply Management

Back to top

The Complete Package
At Sherpa, we believe that every customer deserves our A-team. That’s why we provide fast, flexible, and reliable services for every customer. Our project managers leverage their clinical supply expertise to identify and execute the optimal clinical supply solution for your project. Our operations and processes are built to accommodate ever-changing clinical project requirements and fast turnaround times without sacrificing quality.

Download Sherpa’s core capabilities.

Back to top

Primary & Secondary Packaging
Sherpa designs and supplies packaging in a wide range of materials specifically selected to meet your needs:

  • SBS folding carton
  • Corrugated cardboard
  • Direct print in multiple colors
  • Inserts
  • Die-cut foam
  • Thermoformed plastic
  • Injection molded plastic
  • Thermoform blisters – Aclar®; PVC
  • Coldform blisters- Alu/Alu
  • SBS blister cards and wallets

Sherpa’s primary and secondary packaging services include:

  • Blinded and unblinded patient kit assembly
  • Labeling and over-labeling
  • Solid dose bottling
  • Thermoform and coldform blister packaging
  • Card and wallet sealing
  • Automated insertion of pre-filled syringe rods
  • Sourcing and kitting of ancillary supplies

Labeling, kitting, packaging, and shipping services available at: -70°C, -20°C, 2-8°C, and controlled room temperature.

See all of Sherpa’s primary and secondary packaging capabilities.

Back to top

API Sampling & Storage
Sherpa’s dedicated ISO 8 sampling room is designed to accommodate a wide range of APIs, including high potency APIs (HPAPIs). It is equipped to accurately weigh and aliquot a variety of potent compounds from sub-gram to kilogram quantities – so you can request samples  as often as you need for your research studies, stability studies, etc. In addition, environmentally-controlled and monitored GMP storage facilities are available for your short or long-term storage needs.

Temperature-controlled environments include:

  • LN2
  • ≤-70°C
  • -20 ° C
  • 2-8 ° C
  • 20-25 ° C

See all of Sherpa’s API sampling and storage capabilities.

Back to top

GMP Storage
Sherpa’s state of the art facilities include temperature-controlled storage using an Elpro monitoring and alarm system to support all of your storage needs. Redundant mechanical systems on walk-in refrigerators and freezers provide an extra margin of safety to protect your product.  All cold storage is strengthened with on-site emergency power.

Security and Reliability – Sherpa’s facilities are accessed with key cards that prevent unauthorized personnel from entering the building and controlled areas.  The facility is alarmed and monitored 24/7, including cameras and motion detectors.

Fire Suppression and Protection – All Sherpa storage areas utilize the Argonite fire suppression system, which uses an inert gas that offers effective fire protection with zero environmental impact, having zero ozone depletion potential (ODP) and zero global warming potential (GWP). It is a simple blend of 50% Nitrogen gas with a density similar to that of air. Both Argon and Nitrogen are clean, natural gases that are readily available throughout the world. Argonite is safe and effective with no post-fire residual extinguishing agent or damage to protected product or documentation.

Storage services are available at the following temperatures:

  • Controlled Room Temperature (CRT) 20-25°C
  • 2-8°C Walk-in
  • -20°C Walk-in
  • -135 to -60°C

See all of Sherpa’s GMP storage capabilities.

Back to top

Global Distribution
Sherpa has built an expansive network with your clinical projects in mind, with international depots across the EU, Asia, Australia, and Latin America.

Shipping capabilities include:

  • Pre-qualified shippers for 48 to 120 hours, at temperatures of -20°C, 2-8°C, and CRT
  • Access to pallet-sized temperature controlled shipper
  • Dry ice shippers for products requiring -70°C
  • Temperature monitoring using the most advanced USB devices

See all of Sherpa’s global distribution capabilities.

Back to top

Cold-Chain Logistics
Sherpa utilizes advanced processes to ensure end-to-end temperature control for your drug product. We employ the latest cold chain technologies to store, label, package, and ship your drug product across the US, Canada, and globally while controlling the temperature every step of the way to ensure your drug product arrives to its destination in optimal condition.

Shipping capabilities include:

  • Pre-qualified shippers for 48-120 hours, at temperatures of -20°C, 2-8°C, and CRT
  • Access to pallet-sized temperature controlled shipper
  • Dry ice shippers for products requiring -70°C
  • Temperature monitoring using the most advanced USB devices

Sherpa Cold Transport:
Sherpa Cold Transport provides cold-chain transportation for drug product, clinical kits, and API. Sherpa Cold Transport is Hazmat certified to transport critical drug substances that are hazardous materials.

See all of Sherpa’s cold-chain capabilities.

Back to top

Ancillary Supply & Comparator Sourcing
Sherpa offers competitive pricing on ancillary supplies and comparator drugs through our relationships with qualified wholesalers and manufacturers around the world. We can often secure comparator drugs that have constrained inventory so that your clinical trials proceed on-time. Our team will over-label and kit these ancillary supplies and comparators in the appropriate configuration for your study. Our team manages your inventory so your supplies are ready to be packaged and shipped when you need it. We are dedicated to preserving the shelf-life of these supplies and will coordinate all the logistics, including temperature-controlled shipping.

See all of Sherpa’s ancillary supply and comparator sourcing capabilities.

Back to top

Returns, Reconciliation & Destruction
Having a solid action plan addressing your study’s returns, reconciliation and destruction is necessary. We offer global return and destruction services. Your Sherpa project manager will work with you at the beginning of your project to ensure that your clinical supply needs are met from beginning to end.

At the end of your study, your site can ship unused medical supplies back to Sherpa for material reconciliation. Afterwards, we will store them until you ask Sherpa to send them out for destruction. Sherpa uses a qualified destruction service and will provide you a certificate of destruction for your records.

See all of Sherpa’s returns, reconciliation and destruction capabilities.

Back to top

Labeling Services
Sherpa offers a variety of manual and automated clinical labeling capabilities. Our team evaluates economic, regulatory, and clinical study design factors when designing your primary and secondary labeling to aid user compliance. Sherpa has established manual and automated labeling capabilities. Our team provides guidance around US and OUS labeling requirements, multi-language translation and the type of label that is appropriate for your container type/size.

Label Types:

  • Labels able to maintain adhesion at temperatures of  -70°C, -20°C, 2-8°C, and CRT
  • Multi-panel
  • Booklet labels
  • Blind & double blind labels
  • Scratch-off labels
  • VideoJet labeling
  • Colored text and colored labels
  • Scratch-off labels

Labeling Services:

  • Translation services
  • Comprehensive in-house design and printing
  • Sequential & randomized serial numbering
  • Blind & double blind labels
  • Barcode printing
  • Logo and graphics placement
  • Un-blinding envelopes
  • Creation of randomization lists
  • Instructions for use manuals, patient inserts and instruction cards
  • Translation services

See all of Sherpa’s labeling capabilities.

Back to top

Clinical Supplies Community

Back to top

Sherpa Summer Seminar Photos and Review
The 2017 Sherpa Summer Seminar brought San Diego’s clinical supply community together for an afternoon of thoughtful discussion, and networking. Our expert panels answered the audience’s specific questions on the QP process and the impact of Brexit on future clinical trials.

See the full review and photos.

Back to top

A Note to the Drug Development Community, from a Patient’s Perspective
The daily grind of getting a drug to clinical trial is grueling. When one is lost in the midst of seemingly never-ending paperwork, obstacles, and deadlines, the stress can pile on. Getting a drug to market is a marathon, not a sprint – but ultimately, the pharmaceutical industry is the reason that the world gets innovative, life-saving drugs that improve patient lives. 2017 Sherpa Summer Seminar Speaker, T.J. Sharpe, is a melanoma survivor, and gives us a good reminder of the importance of building strong patient-industry relationships.

Read his full story.

Back to top