High quality and well-prepared data can make the difference in a successful regulatory submission or disappointing delayed approval. Here we bring expertise and quality to data capture, statistical analysis, and clinical trial reporting. From the design of a study through to final submission, trust that your data will be in safe hands with the clinical data experts.
Data Analysis
DATA ANALYSIS
Our Data Analysis team can offer:
Clinical Data Management
Statistical Programming
Biostatistics
CLINICAL DATA MANAGEMENT
We are dedicated to providing high quality clinical data management services to support your product development needs. Obtaining clinical trial data you can trust can save you time and resources. Proficient, active clinical data management throughout the life of a clinical trial requires that data be:
- collected in a controlled way;
- verified for completeness and accuracy;
- monitored for reportable events;
- tracked for trend analyses (e.g., safety signals, investigator performance, etc.); and
- exported for uniform results analyses.
Clinical Data Management We use data integration tools to track your study progress across a myriad of metrics. This process allows for constant monitoring of clinical study site performance and the ability to mitigate potential issues at an early stage. We create customized clinical trial progress reports to meet the needs of all your stakeholders. Our clinical data management team performs appropriate statistical analyses to present clinical trial results that are meaningful and easy to interpret.
- 1ELECTRONIC CASE REPORT FORMS (ECRF)
Web-based eCRFs are worksheets used within an EDC (electronic data capture) system to record clinical trial data in a logical way. Data entered into the eCRFs are mapped directly into the study database according to established standards (e.g., the Standard Data Tabulation Model, or SDTM) to allow for straightforward data analysis that satisfies regulatory expectations. We can create eCRFs that ask the right questions to achieve your clinical trial’s goals in a simple and intuitive way. These eCRFs are customized to suit the project type and individual requirements for streamlined data entry, avoiding the unnecessary delays and potentially inaccurate data that often result from poorly designed eCRFs.
- 2ELECTRONIC DATA CAPTURE (EDC) SYSTEM
An EDC system stores and organizes clinical trial data submitted directly by investigators. Drawing from our experiences working with hundreds of investigators worldwide, we are able to build efficient, intuitive EDC systems that are simple for investigators to learn and use. Clear data forms and simple navigation within the system promote:
- efficient data entry;
- more reliable, higher quality data;
- increased investigator compliance; and
- increased investigator satisfaction, which can significantly reduce clinical trial timelines.
We use real-time analytics and reporting tools to monitor the EDC system and actively manage clinical trial progress, data quality, and investigator performance. Continuous clinical trial monitoring is vital because certain data (such as serious adverse events) are subject to strict reporting requirements. Challenges to clinical trial progress and investigator performance can be identified quickly and resolved before they create a significant impact on the clinical trial timeline. Utilization of an EDC system in a clinical trial also increases efficiency by requiring legible data entries, enabling automatic calculations for cleaner data, and reducing queries about unclear responses.
STATISTICAL PROGRAMMING
Turn your un-interpretable data into something you can understand.
The statistical programming division specialize in the creation of standardized datasets (SDTM or other standards), analysis datasets (ADaM or other standards) and analysis outputs (Tables, Figures and Listings) including Integrated Summaries to support our clients’ submissions. We have specialized experience in integrating legacy studies with recent studies to establish a unified and cohesive package.
Together with our statistical and medical writing team we can assist in planning the client’s data strategy to make sure the submission won’t be held by unexpected demands from regulatory entities.
STATISTICAL PROGRAMMING SERVICES
CDISC – SDTM, ADaM, SEND (pre-clinical), SDTM-MD (Medical Devices)
Metadata – define.xml, SDRG and ADRG
Legacy studies support
Gap analysis according to the latest regulation
Prepare legacy package for submission
Data conversion to CDISC standards
Statistical analysis of clinical data
As part of INDs, IDEs, NDAs, 510Ks, PMAs, ANDAs and BLAs
Study Interim analysis
Custom analysis per customer/regulatory agencies requirements
Meta-analyses of multiple sources
Tables, listings and figures (TLFs)
Data integration and analysis for safety and efficacy summaries (e.g., ISS/ISE)
Periodical and safety committees reports (e.g. DSUR, DMC)
CLINICAL BIOSTATISTICS
Care by the numbers.
With data on your side, you’re better equipped to make thoughtful decisions at every phase in clinical development and commercialization. Our Clinical Biostatistics team digs into your numbers to help you plan, execute, and analyze at every turn.
We can lend a hand with:
Improved drug/device development performance
Smarter trial design
Reduced risk
Focused data insights
Fraud detection
Our team has deep understanding of the following areas:
Group-sequential and adaptive trial design
Data Monitoring Committee (DMC) support
Observational research/non-interventional studies
Biosimilars
Core Biostatistics Services:
Biostatistics Services Offered Through Your Development Journey
| Planning | Study design
Study optimization Clinical development plan optimization Study simulation Strategy development for data integration and regulatory submission Protocol/SAP development Preparation of briefing documents Preparation of and attendance presentation at Health Authority meetings including feedback review |
| Execution | Datasets and TFL production
Data surveillance Application of powerful and innovative statistical methodologies Fraud detection Risk benefit assessments |
| Reporting & Interpretation | Expert review of key results and statistical assessment
Reporting of key results Preparation of briefing documents Preparation of and attendance presentation at Health Authority meetings including feedback review Response to regulatory or other agency questions (ethics committees, reimbursement agencies) FDA Advisory Committee Meeting support, oral explanations with regulatory bodies, etc. |
| Submission | Data integration across studies for safety and efficacy
Input to CTD summary documents Generation of electronic datasets and documentation Rapid response support |