Technology

CDISC Services

CDISC is the most significant development for convenience in data exchange without confusion within the pharmaceutical industry and between the industry and regulatory authorities. After being recommended by FDA, this data standard has been implemented by clinical research organizations, contract research organizations, Pharma/biotechnology companies, and other companies which use or generate clinical data. CDISC standards are employed as a service by many organizations as it brings clarity and simplicity to the clinical data which is now far more organized than before after CDISC standards implementation.


CDISC standards have a direct and strong impact on the clinical development process. CDISC standards define the data structures within the clinical database management system, case report tabulations and analysis datasets. These standards affect several operative functions where clinical data has to be handled or is handled.

RAM Software Solutions Inc has a very deep understanding of CDISC standards and services and believes these help in achieving the miracles in driving the Clinical Research process. Hence provides a number of services on the lines of CDISC.

  • CDISC Mapping Specification Document
  • SDTM, ADaM Domain Datasets Generation
  • Applications Development Using CDISC Standards
  • Legacy Study Conversion
  • ISS/ISE Studies Standardization
  • Comprehensive Validation of SDTM & ADaM Datasets
  • Define XML Document
  • eCTD Development & Validation
  • CDISC Training

Main Services Provided By RAM Software Solutions Inc

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Biometrics

Advancing your drug to regulatory approval in the most efficient and cost-effective manner requires a concentrated effort every step of the way. More..

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Technology

Applications are the lifeblood of any enterprise, supporting every aspect of how business is planned, managed and executed. More..

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Research & Development

Developing software can be a complex and challenging experience. Custom software can have a significant positive impact on business. More..

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Health Care Services

Led by scientific and technical experts, the RAM Software Solutions Inc Biometrics team has the clinical data management and statistical expertise to consistently deliver high-quality data that accelerates your clinical development process. More..

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Clinical Data Management

Effective clinical data management (CDM) is at the core of any successful clinical trial. At RAM Software Solutions Inc, we’ve made the collection and handling of clinical trial data a central part of our entire service offering. More..

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CDISC Services

CDISC is the most significant development for convenience in data exchange without confusion within the pharmaceutical industry and between the industry and regulatory authorities. More..

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Pharmacovigilance

RAM Software Solutions Inc offers complete Pharmacovigilance services, which include data collection, processing, medical review, safety writing, report writing, reporting, signal detection and analysis. More..

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Medical Writing

RAM Software Solutions Inc Medical Writing team provides professional writing services and quality reviews to the pharmaceutical, biotechnology, and medical device industries via individual subject matter experts or full delivery teams, working either onsite or offsite to support medical writing activities. More..