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IND:+91 8754446690
US:+1-972-502-9262
UK:+44-1143520021
info@medicalwritingexperts.com

  • 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.

data-management-processs-medex

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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FAQ

We provides the various types of Clinical Biostatistics Analysis Services and Data Management Solutions including production of a study randomization, protocol Design and calculation of sample sizes and power calculations of clinical trials, all kind of data Analysis from pre-clinical, clinical and epidemiological trials, Database design and setup, managing EDC data, Statistics Consulting and Medical reports writing
Our experienced Biostatisticians and medical writers are good in Clinical Biostatistics Analysis Services, statistical programming, writing the various types of scientific documents such as regulatory and clinical writing, research-related and drug/disease related documents, publication support services, manuscript editing services and scientific publication support.
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.
Medical Writing Experts writes any type of Scientific, medical and technical documentation including Clinical study report (CSR), Clinical Trial Report (CTR), Common Technical Document (CTD), Annual Safety Report (ASR), Investigational New Drug (IND), Pediatric Study Plan (PSR), Investigational Medicinal Product Dossier (IMPD), Periodic Safety Update Report (PSUP), Risk Management Plan (RMP), Statistical Analysis Plan (SAP) and more.
Yes, Medical Writing Experts main motto is to work hands-on with our clients to give 100% satisfaction based on their requirements. From start to end, you can be sure of proactive coordination of our experts. Our teams have the capability to handle any Biostatistics Analysis and Data Management solutions.
Yes. We offer all-inclusive therapeutic expertise across a wide variety of indications. Medical Writing Experts shapes its clinical trials services to meet your requirements. We can provide complete program development, delivery services for any part of a trial that you are looking to outsource or even save failing trials. With our experienced clinical research, medical and scientific professionals, we have an in-depth knowledge that allows us to apply new concepts and innovation into clinical trials.
Let’s connect us through our quick contact form to get an instant call back.
Connect us at
India No: +91-8754446690
Email: info@medicalwritingexperts.com
Website: http://www.medicalwritingexperts.com/

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