The Best Clinical RFPs We’ve Ever Seen

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!

Where to Find Us This Fall

We have a full fourth quarter docket and will be making the global rounds. Below is a list of where you can find our team over the coming months:

OCTOBER 27, 2017
CRISP Meeting
SAN FRANCISCO, CA

NOVEMBER 2, 2017
NECSO Meeting
BOSTON, MA

NOVEMBER 12-15, 2017
Xerimis to exhibit at AAPS Annual Meeting
SAN DIEGO, CA

NOVEMBER 29-30, 2017
Xerimis to exhibit at Clinical Trial Supply – Southern California
LAJOLLA, CALIFORNIA

DECEMBER 6-7, 2017
Xerimis to exhibit at Clinical Trial Supply – East Asia
SEOUL, SOUTH KOREA

Xerimis Expands BD Team

Xerimis is expanding its Business Development group due to increasing opportunities worldwide. This uptick of interest in Xerimis is due in part to the opening of its purpose-built, 13,000-square-foot United Kingdom facility in 2016. This is the second location for the privately held, New Jersey-headquartered clinical packaging provider. Located thirty minutes west of Heathrow and within easy access of London, the MHRA-approved space is designed to receive, store, label, package and distribute clinical supplies worldwide. The facility holds WDA, MIA-IMP, MS and MIA licenses. Three QPs named on the MIA-IMP license provide services ranging from QP Declaration for CTA submission to QP certification of finished, packaged supplies.

This photo shows the new team. From left to right:

Tom Brady

Tom Brady joins Xerimis as Director of BD, North America. In the previous 6 years, Tom has successfully guided global and regional studies to completion with numerous sponsor clients. He brings a microbiology degree and 20 years of business development experience to the team. As his title suggests, Tom will be working with sponsor companies throughout North America to satisfy their clinical supply needs. (tbrady@xerimis.com)

Puvi Bala

Puvi Bala shifts her focus from leading the construction and opening of Xerimis’ UK facility to bringing clients to that facility. A practicing pharmacist, Puvi will be working with sponsor companies in Europe and beyond. She will continue to be one of the Responsible Persons in the WDA license. Her extensive understanding of Xerimis’ UK site will suit her well in her new role as Director of BD, Europe. (pbala@xerimis.com)

Kevin Clover

Kevin Clover accepts his new role of Sr. Director, Global BD after 7 years as the Business Development Executive at Xerimis. In this expanded role, Kevin will provide oversight of Xerimis’ marketing and sales initiatives as well as a particular focus on sponsor clients outside the US and EU. (kclover@xerimis.com)

“We are proud to have assembled this talented and experienced team to support our growth,” said Jim LoCascio, VP Strategic and Business Development. “Xerimis is well positioned to support the packaging and distribution of global clinical studies and our BD team is excited about educating prospective clients on our extensive capabilities.”

Cold Chain Logistics: Which System Is Right for You?

Choosing the right cold chain system is key to keeping trials on schedule and free of logistical headaches. Xerimis guides clients toward suggested logistical plans and helps you to understand how and why we land there.

First, a distinction: Cold chain logistics has become shorthand for climate control at any temperature. Knowing this distinction can prevent confusion when discussing literal cold chain logistics – that is, methods of maintaining frozen or refrigerated states during shipping.

Your product’s cold chain logistical plan weighs fixed factors (product-specific criteria, budget) against variables including projected shipping time. The right balance differs from project to project.

Most trials opt for one of three cold chain logistics methods:

Passive cold chain supply involves no energy input, such as batteries or power, during transport. Products are placed in an insulated fridge or cool pack which can be sent via a standard courier service like FedEx. If the container ships within the projected time frame and behaves as expected, the necessary temperature is maintained through delivery.

Active transport uses shipping containers equipped with battery packs and HVAC. These sustain required temperatures for longer-than-expected time periods. With active transport, your project can weather minor shipping delays. There’s an added step and cost, though: active cold chain supply requires couriers and wide body aircraft specially equipped with charging systems that can power containers throughout transport.

Finally, there’s temperature-controlled ground transportation. Here, a validated truck or van moves supplies from point A to point B. Equipped with backup active HVAC systems in the event of failure, these vehicles’ parent companies also maintain backup transportation in the event that one of their vehicles breaks down.

Larger shipments with higher value products generally opt for active shipment to reduce the risk of excursion, or error. But active containers can be hard to secure, which can stall shipment in instances where early planning wasn’t in place.

Containers required for passive transport are relatively economical and accessible. Opt for a specialized courier when using them, and you reduce some of the risk of taking this more time-sensitive approach.

If you’re sending products to the European Union, tighter temperature control and tracking criteria almost always call for validated shipping methods and the qualifying of couriers to GDP standards.

Whatever the specifics and whichever route you choose, early and active planning is crucial. If you’d like to discuss the logistics of your next project, please contact us.

Tom Brady Joins the Xerimis Team as Director of Business Development, North America

Xerimis Inc. is proud to announce that effective June 1, 2017, Tom Brady has been hired as Director of Business Development, North America. Tom will be responsible for working with sponsor companies throughout North America to satisfy their clinical supply needs.

Tom was previously a Senior Account Executive for Fisher Clinical Services and helped guide global and regional studies to completion for a wide range of sponsor clients. Tom brings a microbiology degree and 20 years of business development experience to the team.

Xerimis Inc. is a privately held, specialized company providing customized clinical packaging services on a global basis. Serving pharmaceutical, biotechnology and clinical research organizations of all sizes and for each phase of clinical development, Xerimis Inc. holds true to the traditional approach of building long-term relationships with clients. Whether clients are currently working on an initial Phase I trial, or are in the midst of pivotal Phase III studies, Xerimis Inc. recognizes that each trial is critical and provides outstanding service and responsiveness to clients so that timelines are met or exceeded.