Biometrics

Biometric Services

Advancing your drug to regulatory approval in the most efficient and cost-effective manner requires a concentrated effort every step of the way. The right data demands the right people with the right knowledge in the right parts of the world.

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. Involved at every phase of drug development – from study design to delivery of the Integrated Clinical Statistical Report – our highly-qualified team of specialized statisticians, programmers, and medical writers have a better understanding of data supporting our therapeutic areas of expertise.

Our global standard operating procedures (SOPs), combined with continuous quality control, ensure consistent, efficient, and comprehensive data that meet all Sponsor protocol requirements.

Delivering high quality data management, superior statistics, and expert report writing, we are responsive, flexible, and knowledgeable in our approach so you can have complete confidence in your data for the entire duration of drug development. We undertake each study with one goal in mind – correctly preparing your statistical data for submission, on time and on budget.

Data Management – Our data management partner team provides high-quality collection, organization, validation, analysis, and quality control of clinical trial data and utilizes electronic data capture (EDC) to expedite data collection.

  • Review statistical section of protocol
  • Protocol & CRF review (consistency between the two)
  • Statistical input & oversight of the Report and Analysis Plan
  • Interpretation of statistical results
  • Summarization of statistical results
  • Documentation of statistical aspects

  • Protocol and CRF Review
  • Prepare Statistical Analysis Plans
  • Prepare Analysis dataset specifications
  • Generate Analysis datasets and/or ADaM datasets
  • SCS/SCE (pooling) database preparation
  • SCS/SCE (pooling) statistical analysis
  • SAS Programming for interim and final analysis
  • Interim Analysis and DMC Support
  • Table, Listing, and Figure Generation
  • Statistical sections of Clinical Study Report, Manuscripts, Investigator's Brochure
  • Integrated Clinical/Statistical Development Programming
  • PK/PD Model Development and Analysis
  • Perform SAS Programming Verification and Validation
  • Provide all Programming documentation
  • Ad hoc or exploratory ProgRAMming
  • SDTM and ADaM data mapping and conversion

Led by a team of experts which includes former FDA government officials, with broad experience and insight in pre- and post-marketing drug regulation, the RAM Software Solutions Inc Regulatory Affairs Department provides comprehensive international support to Sponsors at all stages of the drug development process.

With a long track record of regulatory submissions around the globe, we are well-versed in all aspects of the clinical trial submission process, to both IRBs/ethics committees and to FDA and ex-US competent authorities. Up-to-date in the evolving regulatory requirements by region, every RAM Software Solutions Inc project team is fully-engaged from progRAM initiation to reporting of results across phases I-IV of drug development. Highly qualified medical writers, regulatory staff, data managers, and statisticians work in concert with your team to ensure the clinical, scientific, and regulatory integrity of every project – from pre-IND/IND/IMPD submission through marketing application submission and regulatory review.

RAM Software Solutions Inc has developed and maintains Electronic Common Technical Document (eCTD) capabilities for full NDA filings, which have been validated by the FDA in both mock and actual application submissions. Our dedicated experts are focused on producing the most meaningful, comprehensive, and submission-ready compilation of your non-clinical and clinical data and manufacturing information – ensuring compliance with FDA and other regulatory agency requirements and guaranteeing every phase of trial is correctly focused for optimum results.

Services include
  • Strategic guidance on the clinical development plan of a new product, including new chemical entity and 505(b)(2) applications.
  • Development and submission of pre-IND and pre-NDA Briefing Packages.
    • Formulation of pre-IND and pre-NDA questions to the FDA.
    • Authoring and compilation of briefing package materials.
    • Correspondence with the FDA on pre- and post-meeting logistics, action items, etc.
    • Participation in FDA meetings.
  • Preparation of the Initial IND.
    • Author Clinical Components (e.g., Introductory Statement, Investigators Brochure, and Protocols)
    • Compilation of additional submission components.
    • Ensure consistency in presentation across all component of the IND.
  • Preparation and coordination of responses to FDA Requests for Information.
  • IND Amendments.
    • Project management and strategic guidance for the life of the IND.
    • Compilation and submission of Protocols, CMC Updates, Nonclinical Study Reports, and Clinical Study Reports.
  • Preparation and submission of 7-Day and 15-Day Safety Reports.
  • Preparation and submission of Annual Reports.
  • Preparation and submission of NDA and sNDA as eCTD.

The Regulatory Affairs Department compiles all components of your Investigational New Drug (IND) applications, including nonclinical and clinical summaries, investigator brochures and updates. Leveraging our insight into the specific areas of drug approval and our successful track record of communication with the FDA, we expedite your original IND submission to accelerate the drug development process. Our highly qualified medical writers and regulatory staff apply the principles of good scientific and medical writing when preparing your IND documents, facilitating approval of applications to conduct clinical trials of new drugs.

Our IND associated goals and responsibilities typically include:
  • Pre-IND and Pre-NDA meetings (briefing book preparation, meeting support and attendance, and regulatory strategy guidance).
  • IND submission and maintenance (protocol submissions as IND Amendments).
  • NDA submission supports.
  • IND maintenance (submission and tracking of IND Safety Reports, Annual Reports, and Amendments).

Safety and pharmacovigilance risk management has gained increased importance in global drug development due to a number of recent high profile drug withdrawals and growing expectations from consumers regarding product safety. While RAM Software Solutions Inc is focused on rapid approval of your compound, we also recognize the importance of identifying and assessing risk during clinical trials. To meet increasingly complex and diverse global regulatory requirements, RAM Software Solutions Inc has developed a comprehensive suite of services designed to ensure safety and expedite approvals. This process is monitored by licensed physicians who are trained to provide appropriate oversight and to analyze and evaluate the emerging safety profile of your compound

Services provided by RAM Software Solutions Inc Safety and Pharmacovigilance include:
  • Global adverse event management for pharmaceutical (chemical and biologicals) and device trials
  • Collection, evaluation, analysis, and reporting of safety information, including serious adverse events, unanticipated adverse device effects, and other significant safety events
  • Safety narrative writing including physician review
  • Global Safety Event Reporting System: Providing a safety database for the life of your compound
  • Coding (MedDRA, WHO Drug) of adverse event information
  • Provide expertise on safety-specific national regulatory requirements in the many countries worldwide
  • Preparation and submission of annual safety reports, biannual line listing, and periodic reports to global regulatory authorities
  • Custom safety surveillance including adverse event and laboratory trend analysis for detection of safety signals
  • Pharmacovigilance for marketed products
  • Maintenance of a certified pharmacovigilance system for pharmaceutical companies in the EU
  • QPPV services for all EU countries
  • Preparation of post-marketing surveillance reports, including periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs)

We offer services for the development, implementation, deployment and maintenance of enterprise financial systems. Our experience designing, implementing and customizing applications for security trading, portfolio management, risk management, asset securitization, e-Finance and Financial operations will give your firm the ability to deliver quality integrated financial systems while providing the ability to closely manage the resource investment for their delivery. In addition, we offer several packaged products that can be combined with our consulting and integration services to improve your edge in the market and improve your delivery time.

Service Offerings: You can leverage our services and our experience with the entire development process to help with some or all aspects of the delivery of your Finance project:
  • Architecture and Design
  • Project Management
  • Development
  • Deployment
  • Maintenance
  • Custom configuration and development
  • Integration
  • Packaged solutions

Main Services Provided By RAM Software Solutions Inc

B

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..

T

Technology

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

R

Research & Development

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

H

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..

C

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..

C

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..