Clinical Research

Clinical Research

 

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BrainyPro is the leading provider of SAS Powered software applications and services for the clinical research industry and offers a comprehensive, integrated clinical data management solutions.
BrainyPro’s CRO division offers a complete package of data management, analysis and bio-statistical services. Our biostatistics team of highly skilled professionals can provide data management, SAS® programming and statistical analysis services to meet the clinical trial needs of our clients.
We at BrainyPro have demonstrated proficiencies in all phases of clinical drug development.

 

 

Biostatistics and SAS Programming

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BrainyPro’s biostatisticians have the education and industry experience necessary to execute a data analysis strategy for your studies. Our biostatistics team members have an extensive experience in both clinical data management and statistical SAS® programming.

Our key medical and scientific writing offerings:

Our comprehensive range of biostatistics services covers any clinical trial phase and therapeutic area:

  • Clinical and Statistical SAS programming
  • Statistical Analysis Plan (SAP)
  • Sample Size and Power Calculation
  • Randomization Schedules & Implementation
  • Statistical CRF and Database Review
  • Analysis Dataset Programming and Documentation
  • Tables,Listings and Figures Validation and Quality Control
  • Ad hoc Statistical Support
  • Data Integration
  • Efficacy and Safety Data Analyses
  • Stand Alone Statistical Reports
  • Integrated Clinical Study Reports
  • Custom Application Development:Custom software applications that automate processes, interface instruments, analyze data and integrate systems. Additionally, custom app for data integration, implementation and migration
 
Clinical Data Management:

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BrainyPro offers both electronic data capture (EDC) and paper/fax-based solutions that are customizable and cost-effective for clinical data management.

 

Our key Clinical data management offerings:
  • Data capture and management CRF/eCRF design and annotation.
  • Data management plan writing and maintenance.
  • Creation of CDISC SDTM Datasets database design and maintenance.
  • Data processing and quality control, including third party data integration and cleaning.
  • Database QA acceptance sampling and additional database checks by statistical team.
  • Secure web portal for real-time access to study progress reports, query reports, subject data listings and summary tables, etc.
  • Database archiva
 

Medical and Scientific Writing Services

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BrainyPro’s medical writers work to integrate the medical and statistical results of your trial into an electronic or paper document that meets the needs of the client and the regulatory requirements. The medical writer produces documents that are easily reviewed by the clients and the regulatory agencies.
  • Publications Support
  • Integrated summaries of safety
  • Integrated summaries of efficacy
  • Statistical reports
  • Study reports (clinical and non-clinical)
  • Protocol Development
  • Document Management Services
  • Electronic Document Control
  • Document e-publishing, including rendering to PDF, creating bookmarks and hyperlinks, adding pagination, and processing scanned documents.
 

Clinical Project Management

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BrainyPro’s project managers lead the team of professionals assigned to your project. Our project managers are trained to move your project forward by communicating with all the shareholders in the project and insure processes follow FDA guidelines and internal SOPs. All of our project managers have medical training and backgrounds in clinical research

 

Our key clinical project management offerings:
  • Consulting Services
  • Project Planning
  • Manage Project Timelines
  • Progress Reports generation
  • Manage communication across all shareholders of your project

Contact us today to discuss your clinical research development needs.