Author: wpteam

There is a “super sizing” trend in the clinical supply industry as larger vendors continue to acquire their smaller competitors. In the last year alone, there were seven acquisitions that occurred between vendors. The trend, though, is that these acquisitions aren’t limited by offering. Clinical supply vendors have made inroads into research, manufacturing, commercial contract pharma, and a range of other specialties. While this approach might be great for the companies, the question that it poses is does it benefit the client? Is big always better?

There are significant side effects to this type of growth, and small and mid-sized companies should consider these factors when choosing a clinical supply vendor:

1. As companies continue to grow, so does their workload and timelines can often fall through the cracks. They are forced to become more bureaucratic, creating more obstacles when it comes to decision making, communication, and following regulations.
2. The focus on services tends to drift from clinical supplies to manufacturing and what was once expertise in one area shifts to average servicing in multiple areas; one-stop shops are becoming less popular as companies realize that their customers require specialized needs.
3. Larger public companies demand larger revenue, and smaller clients can be marginalized as the focus turns toward larger clients.

Xerimis services all customers, not just big pharma. Why does this matter? Xerimis doesn’t have the external pressures of private equity metrics or shareholder demands and therefore can focus solely on our customers, their needs, and delivering value for patients. We are a family-owned business that operates as a streamlined internal organization. Building strong relationships is what allows us to cater to personalized needs, and our range of capabilities allows us to handle any large project without missing a deadline.

We believe that by focusing strictly on clinical supplies, we are able to hold a high standard of excellence in our field and stay far from the mediocrity that comes from trying to do too many things well.

Learn more about how Xerimis can support your project.

Blistering – a thin film that lets patients “pop” tablets out of a protective cavity – isn’t as common in clinical packaging as it used to be. The rise of biotech means more vials, syringes, and injectables at play in modern trials. Still, blistering is critical to the protection and integrity of many tablet-based clinical studies, and getting it right is key to trial success.

There are two types of blistering, and many clients rely on Xerimis to help them determine which is best:

Thermoform blistering is a protective film (usually transparent, but sometimes opaque) that’s heated and then formed to the size and shape of the capsule to create an airtight seal when used in conjunction with the appropriate lidding foil.

Cold form blistering is a foil counterpart that does the same job even better. Cold form provides a stronger protection against moisture and is the optimal choice for drugs with water vapor sensitivity.

Blistering decisions aren’t as simple as either/or. Cold form blistering often requires a larger blister card – sometimes by as much as 50%. This may result in blister cards that are not convenient for the end user – your patients. This challenges an industry rule of thumb: patients should be able to fit blister cards into their pockets. The trade-off is often justified by the added moisture insurance that cold form provides. If cold form blisters are required, Xerimis strives through thoughtful design to produce larger blister cards that fold into smaller, pocket-friendly dimensions.

Thermoform: A Question of Moisture

When choosing thermoform blistering, the client has an additional choice to make. There are three thermoform options of varying quality: PVC, PVDC, or Aclar. The least expensive thermoform blistering is straight polyvinyl chloride, or PVC. Few clients can use this option given its limited moisture barrier and the uncertain stability profile of most newer compounds. PVDC – coated polyvinyl chloride – provides a level of protection against moisture. The best of the thermoform options? Aclar, a clear poly-chloro-tri-fluoro-ethylene, meets the highest protective barrier and shelf life standards available in thermoform.

The Right Packaging Makes for Better Trials

Whichever blistering option you choose, it is available in child-resistant, senior-friendly blister cards that have become commonplace in clinical trials – further ensuring positive clinical outcomes and regulatory favor. Reach out to Xerimis for help determining which blistering option best matches your needs.

We see a ton of RFPs at Xerimis. At this point in our growth, we know what information a company needs to provide to determine if we’re a good fit for their trial. But RFPs are still a good way for us to get on the same page with a prospect, some of whom don’t have as much experience in the industry.

The obvious goal of an RFP is a quote, as well as an estimated service timeline. It’s the first outward-facing step toward deciding on a packaging vendor. RFPs (also referred to as RFQs, or “requests for quote”) can provide so much more. The RFP process is a discussion between us and the requestee (sponsor/CRO) that hones in on the finest of details. We’ll pose a variety of questions to the requestee , the requestee has questions for us, and at the end, everyone has a clear picture of the job, who’s doing what, and the costs.

We tend to see two types of RFPs. The first type is what we call ballpark estimates: the requestee knows what services they will need and looks to us to give them an estimated quote based on our experience. These requestees tend to be working on a budget deadline.

In these situations, we need the following specifics:

• Location of clinical sites
• Total number of clinical sites
• Dosage form
• Type of packaging needed
• Approximate quantity

The second type of RFP we call comprehensive estimates.

The RFP provided includes more detailed study specific information. Comprehensive estimates tend to center around temperature requirements, comparative sourcing, treatment group quantities, return accountability and destruction, translation needs, and more.

We guarantee a quote within five business days as long as two conditions are met:

The client fills out the entire questionnaire we send

Unanswered questions lead to an incomplete RFP process and a longer turnaround time. If you have questions as you complete the questionnaire, reach out to us instead of leaving any required fields blank.

Know what service you are seeking

Clinical trial drug packaging’s nomenclature can be confusing. Do you need primary packaging, secondary packaging, label generation, or label assembly? Do you need them all?

A quick refresher course: Primary packaging refers to bottle fill or blistering for tablets or capsules. Secondary packaging is the seal that locks a tablet into its protective blister card or blister wallet. Label generation is the design of labels. Label and assembly refers to affixing them to a fully packaged drug, or putting the fully packaged drugs into a larger kit, if applicable.

Xerimis often receives RFPs with voids about the type of trial being conducted. Is it blinded? Open label? Randomized? These details are crucial to quote generation. Again, a Xerimis team member is happy to provide clarity as needed.

A final note: having the right point-of-contact within a company is crucial. Ideally, we speak to someone in clinical supplies who understands the details of the study. This helps us avoid miscommunication that sometimes results from the information transfer. When we’re speaking the same ‘language,’ everybody wins.

In Xerimis’ experience, a complete RFP is often the indicator of a smooth packaging and labeling process. We look forward to answering yours!