SERVICES 

CLINSERV™ CONTRACT CLINICAL LABEL GENERATION SERVICE

CLINSERV™ is a contract clinical label generation service that provides you with ready to apply clinical labels designed and produced for your specific clinical trial needs. The service enables you to obtain blinded and open label study labeling with a full range of variable data elements. The labels are produced by validated computer systems in a GMP facility. Sophisticated material and patient randomizations can also be provided. CLINSERV™ is easy to use. Our contract labeling professionals will discuss and review the study requirements with you.

CLINBOOK™ MULTI-PAGE CLINICAL LABELS

CLINBOOK™ labels are multi-page clinical labels used to address the needs of multi-language studies. These labels enable users to prepare and ship clinical materials to multiple countries without having to utilize country specific labels. Lifting a durable resealable plastic cover on the top surface of the label allows access to the multi-page section. The cover normally incorporates variable data and globally important information for your study. Each booklet page typically contains non-variable text for one language that may be part of your clinical trial. A title page and an index, which refers to the page number of each language, can also be included because of the large page capacity of CLINBOOK™ labels.

CLINICAL RANDOMIZATION

Our systems can create randomization data for all types of CTM requirements. Patient randomization, material randomization and random sequence coding can be produced to suit your data needs for any type of clinical trial. Data is generated using our validated ClinPro/LBL™ system in a qualified environment.

SOFTWARE

CLINPRO/LBL™ CLINICAL LABEL GENERATION SYSTEM

CLINPRO/LBL™ is the industry’s leading clinical label generation system offering superior overall capability and flexibility. The system enables users to generate all of their clinical labeling and randomization requirements from a rich computer model of a clinical protocol in a Windows™ environment. This method of design specification provides our users with an advanced information tool to ensure that all of their clinical labels will conform to the study and packaging requirements. CLINPRO/LBL™ is a commercially available, targeted application specific to clinical supply operations. The system can be implemented quickly and is cost effective to operate.

SOFTWARE VALIDATION SERVICE

Our knowledge of pharmaceutical industry practices and standards along with regulatory requirements, enable us to create practical and cost-effective solutions for your validation needs. We have been performing computer systems validation for over 15 years. This experience with the validation process ensures that your system is thoroughly tested and documented. Our SOFTWARE VALIDATION SERVICE follows a lifecycle methodology. We can assist you in all phases of the validation process, from the development of the validation master plan to the user acceptance phase.

STOCKS

CLINSTOCK™ is a premium line of label stock products that we supply to the pharmaceutical industry. These label stocks are specifically designed for use by clinical supply departments for the computer printing of clinical study labels. Labels are available from our in-house inventories or on a custom conversion basis. This allows you to obtain the correct combinations of size and structural configuration with the appropriate facesheet, inks, adhesive and liner materials for your requirements. Labels can be finished in fanfolds, rolls, or sheets for use with a variety of computer printer technologies.