Transforming clinical labeling to proactively meet diverse production, supply, and regulatory demands
48時間
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
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.
Exportable artworks and Master Label/Country Label Text (MLT/CLT’s) label content reports
Reduce production timelines to create, approve, and print clinical trial labels in hours
Remove risks, errors, and fines by managing regulations and content with a regulatory rules engine - ensuring compliant labels and outputs for everchanging local requirements
Produce small batch & JIT labels to manage late-stage changes, removing the need for booklet labels
Simplify language requirements by reusing content - especially phrases and translations in clinical labeling production and exportable digital outputs
Provide industry-leading documentation, guidance, and support to aid the validation process
当社製品
業界で最も強力なクラウドベースのソリューションを活用し、臨床ラベル作成とブックレット管理の正確性とコンプライアンスを確保します。厳格な規制要件を満たすように設計され、複雑な臨床サプライチェーンに対応可能です。
臨床ラベリングツールを表示自動化されたワークフロー、組み込みの承認プロセス、リアルタイムのコラボレーションにより、パッケージングのアートワーク管理を効率化します。Loftware Smartflow を活用して、市場投入までの時間を短縮し、規制遵守を確実なものにします。
Smartflow の実際の動作をご覧ください
Accelerate production timelines
Adopt small batch/just-in-time packaging
Global management of regional requirements
Data driven labeling for compliance
Leverage business applications & digital technologies
Simplify validation
Cut timelines by automating the creation, approval, and printing of clinical trial labels and digital outputs.
Clinical trials labeling and content management software enables sustainability-aligned processes by eliminating costly and complex booklet labels, reducing packaging waste, and supporting in-field relabeling when needed.
These innovations streamline operations while enhancing flexibility and compliance.
The Loftware Prisym 360 cloud-based solution was set up in the Cloud and just five weeks later, we had printed our first 1,000 labels ready for packaging.
Since implementing Loftware Prisym 360 Clinical Trials, our label production process at CalCog has undergone a transformation that not only bolsters our operational efficiency but also amplifies our client-centric approach that underscores our commitment to quality, timelines, and cost-effectiveness.
This was an incredibly fast turnaround for what could easily have been a long and arduous onboarding process. It has enabled us to hit the ground running at a critical time for our business and given us a real competitive advantage as we adapt our business model to meet the changing needs of the global clinical trials supply chain.
Just as anticipated, bringing labeling in-house and streamlining processes has allowed us to accelerate production timelines and reduce our costs. Now we have a reliable and efficient internal labeling service that provides stability within the wider business, and we achieved a 100% ROI in less than 12 months. While customers have welcomed the reduced pricing for labels, the consistent shrinking of timelines has proved to be the real game-changer, helping us to attract new business and awaken dormant customers.
RxSource now has full control of its clinical labeling in-house and can get its labels designed and printed within 48 hours. This agility and flexibility are critical business advantages in providing on demand and direct-to-patient services.
We didn’t have confidence in our old software, but it was what we knew. It took us 15 days from the start of the design process to have a usable proof, and there were lots of manual procedures introduced to manage the process. We were fully aware that we needed a clean slate for our labeling processes and that our future approach should be underpinned by a tried and tested industry solution. That software was Loftware Prisym 360, and there was nothing else on the market that could compete with it.
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:
Labeling requirements under Good Manufacturing Practice (GMP) including EU Annex 11 and 13
Provides the framework for Investigational Device Exemption (IDE), allowing manufacturers to ship and test in humans before seeking FDA approval
Outlining the labeling requirements for investigational and auxiliary medicinal products used in clinical trials, including details on the expiry date and other necessary information
Labeling requirements for medical devices and pharma products, including in clinical research
Country-specific labeling standards for China
