Ondersteuning van geneesmiddelenonderzoek en klinische ontwikkeling

Trial master file software and services

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  • Advies over klinische ontwikkeling
  • Ondersteuning bij regelgeving
  • PV-software en -diensten
  • Software en services voor klinische data
  • Operationeel ontwerp van klinisch onderzoek
  • Logistiek voor klinisch onderzoek
  • Productstrategie voor klinisch onderzoek 
  • Klinisch onderzoeksnetwerk

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Guide

Five reasons why your TMF isn’t inspection-ready

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We're here to answer questions and to support your drug research and clinical development needs.

Solutions to achieve TMF health and maintain inspection-readiness

Managing a Trial Master File (TMF) can be a complex undertaking, presenting challenges like maintaining clinical data integrity and security, efficiently managing vast amounts of clinical trial documentation, and ensuring that all documents are complete and up-to-date. These challenges often require vast amounts of resources and lead to increased operational costs and potential delays in clinical trials. 

At Cencora, we offer global coverage with help from hundreds of TMF experts, ready to help you simplify and streamline the entire TMF management process. Our comprehensive suite of TMF solutions work to maintain the inspection-readiness of your TMF, while freeing up your internal resources to focus on advancing clinical trials.

  • Streamline management of TMF processes throughout the study life cycle, from initial planning and study startup to closeout, inspection, and final archive. 
  • Free up your internal TMF resources with our expert TMF study project leads. Achieve seamless, precise TMF migrations and imports, regardless of scale.
  • Integrate with your own workflows and best practices with easily customizable clinical eTMF software. 
  • Incorporate business-enabling technology advances such as machine learning and natural language processing (NLP) via a steady cadence of software releases.
AI-assisted indexing makes TMF management faster, better, and easier. Download our AI case study to read about how our PhlexGlobal eTMF software generated the following results for a mid-sized pharmaceutical company. You can also view our AI Privacy and Data Protection Assurance Statement.
95%
Document classification
accuracy rate
16%
Reduction in 
processing time
6.25
Hours saved per
1000 documents
scanned

Oplossingen

TMF-kwaliteitsbeoordelingen en heatmaps
Voorkom onnodige vertragingen, kosten en moeite met beoordeling door de toonaangevende TMF-experts in de branche en krijg inzicht in en inzicht in de TMF-gezondheid
TMF-documentverwerking
Documentondersteuning beschikbaar wanneer u die nodig hebt, waar u die nodig hebt
  • Ondersteuning van geneesmiddelenonderzoek en klinische ontwikkeling
  • Farmaceutisch
  • Wereldwijd
Projectleiders TMF-onderzoek
Breid uw interne Trial Master File (TMF)-bronnen snel uit met TMF-expertise altijd en overal
  • Ondersteuning van geneesmiddelenonderzoek en klinische ontwikkeling
  • Farmaceutisch
  • Wereldwijd
TMF-risicobeoordeling
Onze branche-experts bieden een holistische beoordeling van uw technologie, mensen, processen en strategie om problemen te identificeren die risico's kunnen opleveren tijdens inspecties.
  • Ondersteuning van geneesmiddelenonderzoek en klinische ontwikkeling
  • Farmaceutisch
  • Wereldwijd
TMF-migraties en -imports
Zorg ervoor dat u voldoet aan de normen van Good Clinical Practice (GCP) en wettelijke vereisten voor essentiële documenten.
  • Ondersteuning van geneesmiddelenonderzoek en klinische ontwikkeling
  • Farmaceutisch
  • Wereldwijd
TMF fusie en overnames (M&A) ondersteuning
Krijg een getrouw beeld van de bereidheid van uw gekochte product voor inspectie of indiening en pak eventuele problemen aan. Beperk risico's, stroomlijn de indiening bij regelgevende instanties en verbeter het algehele succes van uw overname.
  • Ondersteuning van geneesmiddelenonderzoek en klinische ontwikkeling
  • Farmaceutisch
  • Wereldwijd

Products

Global

PhlexTMF Enterprise

Innovative TMF management for higher-quality output.

Global

PhlexTMF Express

Improve inspection-readiness with software built on TMF best practices.

Global

PhlexTMF for Viewing

Viewable, inspectable eTMF archive for closed studies from your CRO.

Global

PhlexTMF for CROs

Give your customers the confidence of TMF health from plan to archive.

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Gids

Verminder de complexiteit van aanvullende sourcing voor klinische onderzoeken

Discover more capabilities

Commercialization support

Build a foundation for a successful product launch and accelerate your speed-to-market across the globe with strategic, integrated, and proactive solutions.

Patient access and adherence support

Address potential barriers to access and increase the speed-to-therapy with our suite of pharma patient support services.

Logistics and warehousing

Leverage our global network, specialized packaging, and customs expertise to ensure safe, secure storage and timely delivery worldwide.

Want more information? 

We're here to answer questions and to support your drug research and clinical solution needs.
At Cencora, we understand that effective Trial Master File (TMF) management is a cornerstone of successful clinical trial execution, regulatory inspection readiness, and long-term document governance. As a global provider of TMF services, we are fully committed to ensuring that all personal data processed within our TMF platforms and services complies with applicable privacy and data protection laws worldwide. TMF Solutions Global Privacy Statement