- Central randomization and code-breaking envelopes
- Design and sample size calculations of clinical trials of any kind; including protocol reviews and co-authoring
- Analysis of all types of data from pre-clinical, clinical and epidemiological trials
- Classical and population PK/PD analysis.
- Interim analyses
- Combining studies, including safety and efficacy summaries for regulatory submissions
- Data Monitoring Committee: statistician for the DMC analysis
- Clinical study report review and programming of case narratives
- Database conversion programming
Data Management Solutions
Our services are flexible, and we intend to make only tailored clinical trial data management program to meet our client’s needs, whether they are for an individual project or a full development program.
- Database design and setup – We create and manage a database to your specifications, design CRFs and can write the clinical trial protocol.
- Electronic data capture – We have vast experience in setting up CRF applications using progressive solutions and managing EDC data.
- Statistics Consulting – We have the expertise to provide recommendations on sample size calculations, randomization and Data and Safety Monitoring Board (DSMB) services
- Medical reports writing – Our multilingual writers produce a wide range of clear, professional products to communicate your findings. Our clinical research reports adhere to guidelines.
Our data Managers play a key role in each clinical trial, from designing the electronic Case Report Form (CRF) to on-time delivery of quality data for statistical analysis. Our team ensures completeness, accuracy, and consistency of the data so that it meets the standards of quality expected for reporting to regulatory bodies.
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See why our customers love Medical Writing Experts
Our team possesses the following skill that helpful in the area of Medical writing, Clinical Biostatistics Analysis and Data Management.
• Thoroughly scrutinize documents requirement.
• They provide comprehensive knowledge of the regulations such as European, US, and international pharmaceutical. (If any)
• Analyses and visualize the output that demonstrates the outcomes of a study.
• They build a clear and consistent documents complaints along with the regulation requirements or appropriate authorities inquiries
• Regulate and coordinate the essential inputs from the clinical & Data management team
• Stage-manage an effective and disciplinary Document review process
Produce the template documents that exactly replicate the complete study information or data analysis report and meanwhile, it meets the international standards requirement.
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India No: +91-8754446690
Get in touch to find out how we can help your organisation.
Our team are ready and would like to speak to you, to understand more about your organisation and how we can help you achieve your goals.