临床试验

Transforming clinical labeling to proactively meet diverse production, supply, and regulatory demands

48 小时

RxSource gets its labels designed and printed within 48 hours

100% ROI

CalCog achieves 100% ROI in less than 12 months

Now we have a reliable & efficient internal clinical labeling service that provides stability within the wider business, & we achieved a 100% ROI in less than 12 months.

CalCog

Keeping your trials on track, one label at a time

The clinical trials industry has gone through unrecognizable change due to decentralization, the growth of biologics, cell and gene therapies, adaptive trials, and the expectation of faster outcomes.

 

Pharma sponsors and their outsourcing partners in clinical supplies need industry specific solutions to manage increasingly diverse production and regulatory pressures. It is vital that product identification software becomes the pivot in content management, label design, and output, to meet demanding requirements.

Output print ready clinical labels

Exportable artworks and Master Label/Country Label Text (MLT/CLT’s) label content reports

Cut timescales

Reduce production timelines to create, approve, and print clinical trial labels in hours

Ensure regulatory compliance

Remove risks, errors, and fines by managing regulations and content with a regulatory rules engine - ensuring compliant labels and outputs for everchanging local requirements

Manage late-stage changes

Produce small batch & JIT labels to manage late-stage changes, removing the need for booklet labels

Support regional requirements globally

Simplify language requirements by reusing content - especially phrases and translations in clinical labeling production and exportable digital outputs

Be validation ready

Provide industry-leading documentation, guidance, and support to aid the validation process

我们的产品

The right choice
for your business

临床试验Loftware Cloud Clinical Trials

使用业内最强大的临床标签系统和手册管理云解决方案,确保准确性和合规性。专为满足严格的监管要求和适应复杂的临床供应链而设计。

探索临床标签工具
效果图管理Loftware Smartflow

通过自动化工作流、内置审批和实时协作,简化您的包装效果图管理。通过 Loftware Smartflow 加快上市时间并确保符合法规要求。

了解 Smartflow 的实际应用

Trial and no error — we’ve got your labeling covered

Staying ahead of compliance challenges

Meeting labeling compliance on a global scale while addressing regional nuances around language and regulations is challenging. Pharmaceutical sponsors, clinical manufacturers, outsourced partners, and suppliers must comply to ensure integrity and patient safety worldwide.

 

Loftware’s clinical trials labeling and content management ensures that you meet requirements at every stage of compliance for standards and regulations including:

FDA 21 CFR Part 11

Electronic records and signatures for compliance in labeling

GMP Guidelines

Labeling requirements under Good Manufacturing Practice (GMP) including EU Annex 11 and 13

FDA 21 CFR Part 812

Provides the framework for Investigational Device Exemption (IDE), allowing manufacturers to ship and test in humans before seeking FDA approval

EU Annex VI

Outlining the labeling requirements for investigational and auxiliary medicinal products used in clinical trials, including details on the expiry date and other necessary information

ISO 13485

Labeling requirements for medical devices and pharma products, including in clinical research

China FDA (CFDA) Regulations

Country-specific labeling standards for China

Additional resources