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Biostatistics
Data Science
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Biometrics Innovation

Biostatistics

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Service Overview：


Biostatistics services is based on the guidelines of regulatory agencies (NMPA and FDA, etc.) and other relevant regulations, combined with the rich experience in pharmaceutical companies and CROs, to provide pharmaceutical companies with high-quality and professional innovative solutions to effectively enhance the statistical efficiency and accelerate the progress of R&D of new drugs.


Applying innovative statistical design methods, saving research cost and speeding up the trial process:
111.png   Apply Bayesian statistical methods to improve the probability of accurately finding MTDs by using experimental design methods such as BOIN, i3+3, mTPI-2, R-TPI, etc. in phase Ia dose climbing. Enhance R&D efficiency through the transparency of decisions and the flexibility and user-friendliness of flowcharts and decision tables.

111.png   In the Phase Ib dose extension trials, use simultaneous multi-dose, multi-indication expansion to save trial sample size, increase flexibility, and save development time.

111.png   Main Protocol and Seamless Design: Simultaneous study of multiple therapeutics or/multiple diseases in a single protocol; Umbrella/basket/platform design for multiple groups or co-controls and simultaneous screening of multiple biomarkers; Full utilization of data from all phases to improve statistical efficacy and shorten R&D time.




Our Services：


111.png   Clinical Development Strategy (CDP) Statistical Consulting

111.png   Trial Design and Clinical Protocol Statistical Support

111.png   Randomization protocol development and implementation

111.png   Statistical Analysis Plan (SAP) and TFL writing and implementation

111.png   Interpretation of study results and report writing

111.png   Communicating with Regulatory Agency Statistical Reviewers

111.png   IDMC/DSMB's third-party independent statistician services

111.png   Statistical consulting and training




Our Differentiations:


111.png   Internationalized business capacity

      Taking the international standard CDISC as the standard data format and following the meticulous requirements and high standards of ICH-GCP, we have the ability to provide dual reporting in China and the U.S. as well as global multi-center services;

 

111.png   Flexible and innovative cooperation model

      Biostatistics full-range service, outsourcing FSP, strategic cooperation with pharmaceutical companies, statistical support, statistical expert consulting and training, assistance in the "management" of the outsourcing statistical suppliers;

 

111.png   Professional Team

      Biostatistics management team: with domestic and international well-known pharmaceutical companies or CRO management experience, an average of 15 + years of industry experience; Core technical team: an average of 7+ years of biostatistical experience in clinical trials of innovative drugs, with rich domestic and international project experience.






Data Science

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Service Overview：


Our data science services are based on CDISC international data standards, and the data management procedures are guided by FDA and NMPA mainstream data guidelines. Providing differentiated and customized services for pharmaceutical companies. UnionLab introduces the Electronic Data Capture system with international advanced technology skill: TrialMaster. In order to align with China clinical research needs, accelerate the data processing, and bring more value to our customer, UnionLab localized the system by deploying domestic servers.




Our Service：


111.png   Data Management Document, include DMP (Data Management Plan), DVP (Data Validation Plan), CCG (CRF Completion Guidance), Coding Plan and Convention, eDTA  (External Data Transfer Agreement), SAE Reconciliation Plan, PDS (Protocol Deviation Specification), DRR (Data Review Report), DMR (Data Management Report), etc.

111.png   CRF/eCRF design (per CDISC.CDASH standard)

111.png   CDMS (Clinical Data Management System) and related modules establish and test

111.png   Online data clean and data status report

111.png   Offline listing program and manual review

111.png   Medical event and drug coding

111.png   External data reconciliation

111.png   SAE (Serious Adverse Event) reconciliation

111.png   PD (Protocol Deviation) management

111.png   (Blinded) Data Review Meeting management

111.png   Database lock and raw data transfer

111.png   Data management consulting and training

111.png   TrialMaster system training




Our Differentiations:


The Data Science management team own more than 10 years industry experience. The data management teams have more than 5 years industry experience and own rich international and domestic clinical trial data management experience. The database programming team has more than 7 years industry experience and familiar with international and domestic clinical data management system. Both the data management and database programming follow the national agency regulations, support both regular data processing and specific data requirement, such as interim analysis, seamless bridge the source data and analysis requirements, meet the real-time needs of clinical data.



Statistical Analysis and Programming

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Service Overview：


Our statistical analysis services are based on CDISC international data standards, independent double-programming quality control processes, and data submission standards guided by US FDA and China NMPA mainstream data guidelines. It provides high-quality, efficient, and professional data analysis services for pharmaceutical companies, offers rapid and accurate data analysis support for key clinical decisions, and accelerates the development of new drugs.




Our Service：


111.png   CDISC Standard Data (SDTM/ADaM)

111.png   Statistical analysis Tables, Figures, and Listings (TFLs)

111.png   Interim analysis and support for IDMC statistical analysis

111.png   NDA/BLA eCTD M5 electronic data submission for new drug market approval (including Case Report Form (CRF) annotations, SDTM, ADaM, Define files, cSDRG and ADRG, etc.)

111.png   Integrated Summary of Safety/Efficacy Analysis (ISS/ISE)

111.png   Data analysis support for other clinical services (IND, PD, CSR, SMC, MMR, DSUR, etc.)

111.png   Preclinical and clinical pharmacology data statistical analysis

111.png   IRC data management and standardization

111.png   Consulting and training on data standards




Our Differentiations:


Nearly half of our team members have more than 6 years of industry experience, boasting rich experience in statistical analysis of clinical trials both domestically and internationally. Statistical programming work follows the internationally leading CDISC data standards, with double-blind programming to ensure delivery quality and fulfill various analytical requirements stated in the statistical analysis plan. The team can smoothly meet submission requirements of various regulatory agencies (such as FDA, NMPA, etc.) and handle their mutual conversions and integrations.

Union Laiya is a corporate member of CDISC and could fully utilize the resources and support provided by CDISC to its corporate members for the benefit of our clients.


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Biometrics Platform

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Service Overview：


TrialMaster is global leading EDC system developed by American Anju company, which combines various modules include both the basic modules such as Coding, IRT, ePRO, etc., and the advanced modules such as Translation, SafetyLink, Acuity Analytics, etc. The main architect is from Medidata, and the system frame is on the same page with Medidata RAVE. More than 400 projects and 20 products was approved by FDA on TrialMaster. After expanding to China market since 2018, already has product approved by NMPA as well. UninonLab obtained TrialMaster official authorization at 2020, localized the system by deploying domestic servers and obtaining the real-time data for dynamic decision from mobile end.




Our Service：


111.png   TrialMaster EDC

111.png   TrialBuilder

111.png   TrialExplorer

111.png   Auto-Encoder

111.png   Local Lab Range

111.png   IRTMaster

111.png   eLearning

111.png   Translation

111.png   File import

111.png   Data export

111.png   SafetyLink

111.png   OmniConnectAPIs

111.png   AnjuDV




Our Differentiations:


      TrialMaster specific system functions:

111.png   Easy to access and use

      Adopting Liquid Layout adaptive interface design, the system can automatically adjust the screen display size when users use different devices, making it very convenient for users to use on screens of different sizes.

111.png   Real time feedback on query

      Users receive real-time guidance feedback when entering data, thereby minimizing data input errors and expensive data cleaning costs.

111.png   Multi language support

      TrialMaster can be translated into any number of other languages and stored in a global translation database. Users can choose the system language they want to use.


      UnionLab localized EDC system characters:

111.png   Localized deployment, localized technical support

      The system server is operated and maintained by the UnionLab Intelligent Development Team in China.

111.png   More in line with the practical needs of clinical research in China

      While following the upgrade of the original system version, the development team of UnionLab Intelligence is responsible for updating the detailed functions.


      Technical functions are consistent with international frontline EDC systems, and FDA compliance requirements:

111.png   Complete audit trial, automatically recorded by the system, accurate to seconds

111.png   Independent laboratory module, independent medical coding module, powerful data reporting function (customized reports)

      When the site personnel enter lab data value, TrialMaster will automatically fill in the matched local lab normal range and units on the eCRF page, automatically judge the test results as "low/high/normal” and provide clinical significance for outliers immediately. Related medical terms will be automatically encoded, and if no matching terms are found, they will be marked as manually encoded. A concise and user-friendly coding interface helps authorized personnel to carry out coding work quickly and efficiently. Real time data insights and analysis graphs can help reduce regulatory risks and improve data quality and compliance.

111.png   Accurate authority management

      Through central user management and single sign on functionality, users only need a single username/password to access all of their research and perform personal ID authentication.









Biometrics Innovation

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Service Overview：


In addition to providing traditional biostatistics, data management, statistical analysis and programming services, UnionLab Laiya also offers numerous innovative services related to quantitative science, clinical trial data, and new technologies, aimed at better serving the scientific and efficient planning, design, implementation, and submission of clinical trials.




Our Service：


111.png   Clinical development plans for multiple therapeutical areas with our seasoned partners and experts

111.png   Innovative study designs and development with our professor-level experts and partners

111.png   CDISC standard implementation strategy and consulting

111.png   Risk-based monitoring (RbM) consulting and implementation

111.png   Innovative data visualization tool development

111.png   Decentralized clinical trial (DCT) implementation consulting (co-development with partners and experts)

111.png   R language implementation and training (co-development with partners and experts)




Our Differentiations:


111.png   Our own experienced professional and experts

111.png   Partnership with multiple academic and industry experts