Clinical label production is typically on the critical path to bringing an investigative drug to market for a simple reason: No clinical trial can take place without labels. Even if the protocol is approved, the investigational product (IP) and comparator are on hand, the clinical supplies are in place, the sites are lined up and ready to recruit patients – in short, if everything except the labels are in place, the clinical trial cannot proceed. Yet, labels are often perceived as an afterthought of the clinical supply or package process and adequate consideration of clinical label design and execution has significant implications for the patient, your patient adherence and ultimately recruitment success.
Clinical labels aren’t just stickers that you slap on a bottle. Patients and sites rely on the label to convey critical information and regulatory agencies require specific text. So, how do you juggle these needs in a manner that meets regulatory requirements while best addressing the needs of the patient? This webinar will explore the impact of clinical labels design and execution on the patient and site experience.
From translation of text to highlighting key pieces of information, this webinar will:
- Identify best-practices for eliminating label text translation bottlenecks and ensuring error-free translations for the patient and the site
- Detail clinical label design strategies that balance regulatory requirements with the needs of the patient and the site
- Present strategies that enable you to build flexibility into your clinical label design and production process
- Analyze the implications of clinical label translation, design and production decisions on the patient and the site and identify solutions for driving patient adherence
Kevin Shea, Label Program Director, Clintrak Clinical Labeling LLC., Part of Thermo Fisher Scientific
Kevin began his career at Clintrak in May 2004 in the Manufacturing Division and was directly involved with label production. He was promoted to the Project Management Department where he worked closely with clients in order to insure the successful completion of their jobs from protocol interpretation to label production. Throughout his tenure, Kevin has gained broad knowledge of the clinical label production process and the clinical supply chain as a whole. Over the past few years, Kevin has been an integral part in the development of translation and regulatory review solutions for clinical trial labels.
Kevin provides customer service support including client and site visits, quarterly meetings, trade meetings, exhibitions, seminars and industry lead discussion groups. He works closely with Clintrak specialists to develop customized solutions to meet client’s unique needs.
Kevin received his Bachelor of Arts degree from Hobart College in the year 2000. He currently resides in Patchogue, NY with his wife and two children.
Who Should Attend?
Clinical teams, plus professionals in clinical supplies, logistics and outsourcing, including those working within:
- Clinical operations, clinical supplies, investigational supplies, investigator sites, clinical packaging, clinical labeling, clinical quality assurance/quality control, regulatory affairs, clinical project management, clinical development
Fisher Clinical Services
Fisher Clinical Services is the world’s leading provider of clinical supply chain services.
With a network of cGMP facilities strategically located across the globe to support the conduct of clinical trials, we offer worldwide support for all aspects of clinical supply management including comparator, co-medication and ancillary supply sourcing, packaging, labeling, distribution, storage, through to returns and destruction. With more than twenty years of experience exclusively focused on clinical trials, we can offer guidance and full logistics support across all types of clinical programs and projects.