Clinical Data Management, Statistical Analysis/Programming & Pharmacovigilance

孜孜不倦地学习,不断对自己所学的知识提出问题,仔细考虑这些问题并用自己的智慧分析问题。坚持不懈地把你的想法付诸实施

“Learn avidly. Question it repeatedly. Analyse it carefully. Then put what you have learned into practice intelligently.”

– Confucius

Above all, the purpose of Clinical Data Management and Statistical Analysis/Programming are to ensure the reliability, integrity and accuracy of your clinical data.

Quality stems from design, and so it follows that quality data stems from a well-designed, scientific-based Protocol and Case Report Form (CRF). But data management and analysis are on-going processes and if you want quality to survive any process, you need to have assurances in place to maintain standards throughout. That is why it is imperative that your data is managed by a team with the expertise and training to strictly follow GCP guidelines (and other related regulations) and that are supported by a robust Quality Management System.

Meta Clinical Technology Co. Ltd (Meta) is a wholly owned subsidiary of CSC. Through Meta we provide a full-range of Data Management, Statistical Analysis, Statistical Programming and Pharmacovigilance services to our clientele across the globe. At Meta we work to the highest industry standards so that our deliverables meet all international health authority requirements – FDA, EMA and PMDA – including the US FDA 21 CFR part 11 and the NMPA "Technical Guideline of Electronic Data Capture in Clinical Trials."

In particular, we recognise there is an increasing global requirement for Clinical Data Interchange Standards Consortium (CDISC)-based data for regulatory submissions. Which is why at Meta, we have proactively addressed this need by training our staff and developing innovative solutions for creating data that adhere to current CDISC Study Data Tabulation Model (SDTM) specifications.

How we can help:

Data Management

  • Data Management Consultation
  • CRF Design/Review
    • Including Annotated CRF and CRF Completion Instructions
  • Database Design and Set-up
  • Data Management Plan and Report Development
  • Data Validation Plan Development
  • Data Entry and Verification
  • Data Validation and Cleaning
  • Query Generation/Resolution
  • Serious Adverse Event Reconciliation
  • External Data Reconciliation
  • Medical Coding
  • Data Review Meeting Support
  • Audit of Data Quality

Statistical Analysis

  • Statistical Consulting
  • Protocol Development:
    • Study Design
    • Protocol input
    • Sample size calculation
    • Statistical methods
  • Randomization Code Generation
  • CRF Review
  • Data Validation Plans Review
  • Statistical Analysis Plan Development
  • Statistical Analysis Report Development
  • Table, Listing, Figures (TLF) Mock-up Shell Development
  • Statistical Analysis
  • Statistical Review
  • CSR Review
  • Data Monitoring Committee (DMC) Support
  • Data Review Prior Database Lock
  • Un-blinding

Statistical Programming

  • Analysis Data Sets (ADS) Development
  • CDISC SDTM Mapping and Transfer
  • CDISC ADaM Dataset Development
  • Programming of Protocol Deviations
  • Programming of Analysis Populations
  • Database Lock and Transfer
  • Quality Control of Database
  • Statistical Analysis Programming
  • TLF Programming
  • Quality Control of TLF programming

Pharmacovigilance

  • Intensive Drug Monitoring
  • Drug Safety Information Management
  • Individual Case Safety Report
  • Literature Searching and Processing
  • Signal Detection and Management
  • Creation, Translation and Review of Periodic Safety Update Reports
  • Creation, Translation and Review of Risk Management Plans

More About the Clinical Service Center CRO

OUR LEADERSHIP TEAM

Leadership

Our senior managers and executives were trained in the West, have worked for big Western pharmaceutical companies, and are committed to bringing the best clinical practices to China.

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OUR HISTORY

Company News

For more than a decade, Clinical Service Center-“CSC” (formerly Beijing Clinical Service Center – “BCSC”) has been conducting top-quality clinical trial services in China for pharmaceutical, biotech, and medical device companies the world over.

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FULL SERVICE PLUS

Full Service Plus

At CSC we define our business scope as “full-service plus” because we go above and beyond the requirements of a traditional full-service CRO to provide you with the end-to-end services you require to get your product in to the China market.

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