Our Services
At Lexicon Scientific we can work with electronic data capture systems such as Prelude and Medrio, with scanned data via portals, or with paper-based data, as required.
We can organise your data, review it, tabulate it and generate a concise report, or scientific paper, that complies with all relevant standards and guidelines.
We will also highlight any data deficiencies or anomalies, document deviations, generate notes-to-file and provide any additional support that is required during the submission phase of your project.
DATA MANAGEMENT
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It is critical that the data presented in your report or publication is 100% accurate. Lexicon Scientific offers the following data management solutions:
- Data Capture Form design
- Data review
- Data cleaning
- Data entry
- QC checking of data
- Data tabulation
- Graphical representation
- AE classification (VeDDRA)
- Managing Statistical Analysis
- SAS database creation and validation
- Preparation of SAS statistical analysis programmes
- Writing of comprehensive statistical reports, with emphasis on clear descriptions of findings
- Preparation of SAS materials (databases, programmes, outputs and logs) for electronic submission (e.g. FDA/CVM)
SCIENTIFIC WRITING
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At Lexicon Scientific we have extensive experience in the interpretation of study results and data. Our writing services include:
- Study Design
- Study Protocols
- Study Reports
- Scientific Publications
- License Applications
- Methods
- SOPs
REGULATORY SUPPORT
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Lexicon Scientific can provide the following support during the submission phase of your project:
- QA Responses
- Discrepancies/Anomalies
- Deficiencies
- Deviations
- Notes to File
- Wording of ReadMe Files
- TMF compilation
- Responses to queries from regulatory authorities