Bulk/Non-Uniquely Number Kits in a Study

Clinical Studies

If the Kits in a study are not identified with a unique number (Kit Number), then the study is intended to make use of the advantages of Bulk/Non Uniquely Numbered Kits.

This concept of Kits can be generously used to distribute and assign blinded Kits, like Open-label Rescue medication, Run in Kits and this is the best concept to handle ancillary supplies.

Clinical Trials that are completely unblended, uses this concept for their full advantage.

Advantages

Avoid the processes followed for Discrete/Uniquely Numbered Kits – This will cut down the cost and timelines of a study, by passing the activities of discussions, generation, approvals, reviews and testing Kits Randomization Lists of both Dummy and Live Kits.

Fewer errors – The Kits Randomization list is always error-prone, just one wrong entry in the list may have meager to catastrophic effect on the study. So, SMEs always suggest taking this up only when this is completely necessary and use the advantages of Bulk kits.

Labels - Label creation is less tedious and simple when it is in Bulk, as there won’t be any need to share the kit number in advance.

Limitations

The Unique Device Identification (UDI) is a system that unambiguously identifies a medical device through its distribution and use within the healthcare supply chain. UDI is comprised of two parts i.e., Device identifier and Production identifier.

  • Cannot be used if all the Kits Types in a Study are blinded. (This can only be used if at least one kit type in a study is unblinded)
  • Individual Kit cannot be tracked
  • Individual Kit cannot be accounted

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Labeling Changes & Challenges to Comply with EU MDR

The introduction of European Medical Device Regulation (EUMDR 2017/745) gives great importance to the end user to assist with the safe and proper use of a medical device(s). The EU MDR and other UDI-type of regulations is causing more and more medical device companies to revisit their labeling processes. EU MDR introduces additional information that needs to be included on labels, forcing organizations to re-design the label templates that make room for data not previously part of the labeling system.

According to EU MDR .....

“The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.”

Harmonized Symbols

Under the EU MDR addition of symbols is a new field on their labeling documents. The usage of symbols helps to manufacturer and also avoids having to provide the information in multiple languages in labeling documents. The MDR regulations allow that the information supplied by the manufacturer can be provided as internationally recognized symbols (ISO 15223).

CE Marking

The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity" with health, safety, and environmental protection standards for products sold within the European Economic Area. The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents.

Warnings & precautions on label

This change will probably have the biggest impact. MDR mandates all warnings relating information to a device must be printed on the label. Regulation says information can be kept to a minimum – with more detail in the IFU.

UDI system

The Unique Device Identification (UDI) is a system that unambiguously identifies a medical device through its distribution and use within the healthcare supply chain. UDI is comprised of two parts i.e., Device identifier and Production identifier.

  • A Device Identifier (DI): a mandatory, fixed portion of a UDI that identifies the specific Product Number of a device and the labeler of that device; for products, this is the GS1 Global Trade Item Number (GTIN); and
  • A Production Identifier (PI): a conditional, variable portion of a UDI that identifies one or more of the data elements (e.g., lot, batch, serial number, etc) when included on the label of the device:

EU MDR requires UDI label be directly attached to a medical device or to its packaging. So all the labels must include PI (GTIN) and DI components as textual and barcoded content.

Labeling Digitization: Manage Data, not Documents

Labeling Digitization: Manage Data, not Documents

Maintaining Regulatory compliance at all times coupled with stringent timelines is an ongoing obligation. Creation and maintenance of labels or label documents is a continual process to any MAH since they have to collect and implement all the necessary changes in the label documents for regulatory approvals and compliance. Health authorities also communicate to the MAHs on updating information via notifications/amendment notification letters. In this regard, MAHs are responsible to collect product specific updated information from various sources and update core label information for each product on a time basis. Currently, this is done with a lot of manual processes that repetitive in nature and sometimes causing people burnout. Resorting to offshoring doesn't help much because of continuous oversight and attritions. Digitization of labels and utilizating technology solutions for end-to-end labeling operations using automation and some artificial intelligence (AI) will be the future.

Topics Covered in this Whitepaper Include:

  • How Core Data Sheet is Different from a Label
  • Label Data Points
  • Local label Content Management
  • Advantages with Digitization & Automation

Please fill the form to Download Whitepaper

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We are Direct to Subject Ready

The advantages of the D to S is multi faced for Subjects, Sites, CROs and Sponsors. We recognized the increasing significance of D to S which inspired us the build this features into our system. Our D to S is build to overcome unique challenges that come with this model.

Supplies Distribution: Supplies can be distributed based on a verity of parameters. This includes discrete & bulk kits with automatic and manual shipments based on buffer and prediction strategies. Fully capable of handling blinded and unblined supplies and personnel.

Supplies Accountability: Simple, user friendly UIs powered by semi automatic functionality makes us the market leader.

Partial Direct to Subject: Subjects can be engaged at local hospitals/labs for dispensing the mediation and collecting other details required IRT. There can ‘n’ number of satellite sites for a given site that can be controlled centrally.

Full Direct to Subject: Full direct subject parameters are capable delivering medication and other trail related activities at the door steps of Subjects.

mIRT Integration with Supplies Vendors: We are two way integrated with leading Supplies Vendors to carry out Full and Partial Direct to Subject activates across the globe.

Support: flexible, quick, user-friendly, accurate, reliable, and esthetic tool backed up by experienced Technical and Subject Matter Expert teams.


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