Life Sciences & CRO

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Over the last decade, patent expiry, generic competition and declining revenues have been the challenges in the pharma and biotech industry. In order to meet these challenges, Contract Research Organizations (CROs) are responding to emerging trends by constant improvement of service offerings. Engaging quality workforce on time is critical for the drug or medical device manufacturing companies to focus on strategies that increase the success of the Clinical Trials and to introduce innovative products to market.

ALTEN Calsoft Labs works with bio-pharmaceutical and other life sciences companies with extensive therapeutic, scientific and Analytics Expertise to help customers maneuver an increasingly complex healthcare environment. Our company works with Life Science companies including CRO, Pharmaceutical, Biotechnology and Medical Device Organizations, in providing quality consultants, to work in Phase I to Phase IV of Clinical Trials.

The consultants have experience working in therapeutic areas like Oncology, Cardiovascular, Dermatology, Infectious Disease, Neurology, Pharmacology, Alzheimer’s, Immunology, Gastroenterology, Ophthalmology, Hematology and Vaccines. We engage in staff augmentation, managed T&M, managed projects and turn key projects with various onshore, offshore and near shore companies. We offer a portfolio of services that includes advisory services like strategy planning, clinical trials execution and real world data and analytics and technology services like patient and provider engagement and product marketing.

As SAS Institute Silver Partner, ALTEN Calsoft Labs works with CROs, Bio-technology, Pharmaceutical and Medical devices companies in providing workforce and consultants specialized in SAS Programming, Bio-statistics, Clinical Data Management, CDISC and FDA standards. Our resources work directly/indirectly with 9 of top 10 pharmaceutical companies.



SERVICES

  • Biostatistics

  • SAS Programming

  • Clinical Data Management

  • Engagement Model

Our consultants have experience in all phases of research and development and work from pre-clinical to product environment. We offer the below services.

  • Independent Statistician Services
  • Consultants with the below skills and exposure:
    • Clinical Trial Design and Protocol Development
    • Sample Size Calculation and Justification
    • Randomization Schemes
    • Statistical Analysis plans for different phases of clinical trials
    • SAP for briefing documents to regulatory agencies and publications
    • Data Monitoring Capabilities
    • Independent Statistician Services

Our 1 to 12 years experienced SAS Certified Professionals work in Phase I to Phase IV of Clinical Trials with the below expertise.

  • Core Skills: SAS/BASE, SAS/MACRO, SAS/GRAPH, SAS/ODSSAS/STAT, SAS/SQLCDISC SDTM and ADaM Datasets
  • Other Skills:
    • Development of Macro tools
    • XML outputs for FDA regulatory submissions
    • Creation of Case Report Tabulation
    • CRTs using CDISC standards
    • Data Analysis and Report Generation
    • Assistance in ISS and ISE programming for Integrated Summary Report (ISR)
  • Process and Standards:
    • CRTs using CDISC standards
    • XML outputs for FDA regulatory submissions

Our consultants are specialized in managing Clinical Data and worked in standards like 21 CFR Part 11 and protocols.

  • Management of Data Review and Clean-up Process
  • Data Management Plan Creation and Maintenance
  • Data Quality Standards Management
  • Development of CRF and Database Validation Processes
  • Database designing to support clinical studies
  • Support Validation of Entry Screens
  • Support DRCs, Protocol, Query Resolution Processes

As a SAS Institute Alliance Partner, ALTEN Calsoft Labs provides consultants specialized in SAS Programming, Bio-statistics, Clinical Data Management, CDISC and FDA standards. Leveraging our extensive deep industry process expertise with major Vendor Management Systems (VMS), passion for customer excellence, proven global workforce solutions, on demand delivery model and global network, we offer best of the breed staffing solutions for rapidly growing enterprises.

  • Contract Staffing: We’re ready with an expansive database of qualified consultants for a quick turnaround deployment. Our consultants are certified by SAS Institute and are extensively trained to work in Clinical Trial projects.
  • Consulting and Outsourcing: We bring onboard the right technology, infrastructure, people and process to make your project a success. The consultants have experience working in therapeutic areas like Oncology, Cardiovascular, Dermatology, Infectious Disease, Neurology, Pharmacology, Alzheimer’s, Immunology, Gastroenterology, Ophthalmology, Hematology and Vaccines.

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