Clinical trial materials are crucial components of the research process, and ensuring that these materials have a significant impact is vital for the trial’s success. GSB Clinical can take the stress out of a complex research process by printing, sourcing and distributing all materials needed for your clinical trials.
Clinical trial materials with significant impact
Well-designed and informative materials not only facilitate participant understanding and engagement but also contribute to the overall integrity and credibility of the research. These materials encompass a wide range of documents, for example:
- Clinical trial protocols
- Trial master files (TMFs)
- Investigator trial master files (ITMFs)
- Investigator trial files (ITFs)
- Investigator site files (ISFs)
- Informed consent forms (ICFs)
- Patient booklets
- Patient diaries
- Patient id cards
- Patient leaflets
- Flip cards – ICF presentations
GSB Clinical’s graphic designers and pre-press personnel make both layouts and technical corrections for all types of clinical trial materials. All our printing machines and finishing equipment are state-of-the-art, and we can meet all customer product requirements in-house, and we ensure high quality in all services.
A partnership that gives you peace of mind
GSB Clinical is the only European printing company with vast experience in customised clinical trial solutions and specialized employees with thorough knowledge of medical terms under one roof. This unique combination enables us to run a seamless digital, graphic, printing and logistic workflow that ensures user-friendly clinical trial solutions for investigator staff and patients.
We work with Europe’s top medical and biotech companies and have more than 25 years of experience in designing and producing products, services and logistics for clinical trials. Consequently, our team has a deep understanding of processes and workflows in the clinical trial printing, storage and logistics arena.
Equally important, we have a comprehensive and solid take on the services that pharma customers require of us to fulfil their demands in the clinical trial printing and logistic process. We also ensure that our services, products and processes keep up with the ever-changing world and the requirements and needs of our customers.
Smooth out your clinical trial processes
Processes are of utmost importance to work efficiently, handling numerous customers’ and business partners’ printing, sourcing and distribution workflows simultaneously and on time. GSB Clinical’s top four focus areas are:
- Quality manual: In cooperation with major pharma companies in Denmark, we have prepared a quality manual that covers all relevant standard operation procedures (SOPs) for clinical trial printing. The manual is continuously updated.
- Order flow: Most orders are handled through our customized web-based ordering and warehousing system. The platform is an intelligent, data-driven system for ordering, warehousing, and enterprise resource planning (ERP). Each customer will have their company URL and platform administrator who can tailor access for each employee, allowing them to enter the platform with personal logins.
The platform can be used for two purposes: As an ordering system or as an ordering and warehousing system. Inventory maintenance is a possibility for customers using the warehousing system. Both options can provide quotations and an overview of all past and present clinical trials, as well as searches and statistics at the job and product level for each country.
A production manager manually enters orders received by phone or e-mail into the system to ensure uniform order handling, i.e., a nine-step process that includes all relevant phases, information, and technical specifications.
- Quality and security: Our flat organisational structure accommodates customers with high demands and clear responsibilities around quality and security. We make sure that our suppliers and partners meet the same requirements as we ourselves are subject to from our customers by conducting regular evaluations.
Users have personal passwords, and only relevant personnel can access file servers. All computers are installed with antivirus software, while a hardware firewall controls access to the company network.
Only internal personnel have access to our printing facilities, and they have all signed a non-disclosure agreement, which is reviewed and updated annually.
All storage facilities are locked.
Printing and logistics partner of the clinical trial materials
Creating an overview of all the documents to enable a comprehensive assessment of the clinical trial and the data quality requires a blend of expertise and logistic finesse. With more than 25 years of experience in clinical trial printing and logistics, GSB Clinical fully understand the services our customers require to fulfil their demands in the printing and logistics process.
Customised storage for clinical trial materials
GSB Clinical’s warehouse is located next to our print house and offices in the Copenhagen area. With a capacity of 1,500m² and an unlimited storage period, we offer separate spaces to our customers for all clinical trial materials, including third-party products. If sensitive materials are stored, climate control is accessible. Because the confidentiality of customer materials is our top priority, all customers will have a locked storage room with a separate door entrance.
Shipping for clinical trials
Based on our in-house printing and warehouse facilities, GSB Clinical stores, picks and packs packages for shipping daily. We work closely with a carrier company specialised in pharma logistics with experience in worldwide distribution; they pick up current-day shipping consignments every afternoon.
