ALTEN Calsoft Labs works with pharma, medical, biotech, CROs, nutritional and cosmetic companies CRO, Pharmaceutical, Biotechnology, and Medical Device Organizations, in providing quality consultants, to work on Clinical Trials (Phase I to Phase IV) and PV services.
As a SAS Silver Partner, we have trained, certified biostatisticians, clinical data management, CDISC and FDA experts who support clinical, pre-clinical and patient-reported outcomes for pharmaceutical, medical devices, and biotech companies.
Leveraging in-house talent pool of 220+ SAS Programmers (80% SAS certified), Biostatisticians, Industry experts, we deliver Biostatistics, clinical data management, Automated trials and complex statistical data analysis models and plans. Our biostatisticians have amassed extensive knowledge pertaining to clinical trials and operations that help deliver critical thinking to help clients accelerate their journey towards connected trials for achieving better health outcomes.
Our consultants possess in-depth experience in statistical areas including adaptive design, personalized medicine, precision medicine and Bayesian analysis.
Seamlessly integrated with ALTEN and harnessing a global delivery network comprising 28,000 consultants spread across 20 countries, ALTEN Calsoft Las delivers next generation, futuristic solutions across the care continuum.
- Registries, Epidemiological studies
- PK/PD modelling
- Clinical Trials
- Phase I, Phase II, Phase III and late phases study
- Statistical design, methodology and sample size estimates
- Clinical Trials protocols
- Statistical Analysis plans
- Adaptive Designs
- Tables, Figures and Listings (TFL)
- Data analysis in line with ICH GCP using SAS
- Statistical Clinical Study Reports
- CDISC AdaM datasets
- Clinical Trial Data Management Systems
- Pre, and Post clinical trials in line with ICH GCP
- 21 CFR Part 11 compliant eCRF with randomization, drug dispensing, Lab values, ePRO
- Documentation, Medical Coding, Data conversion (SDTM CDISC)
- End-user training
ALTEN Calsoft Labs offers pharmaceutical, biotech and med-tech companies full cycle Phase I-III and late phase clinical studies for drugs and medical devices leveraging consultants across NAM, Central and Eastern Europe.
- Infectious Disease
Clinical Ops & Research
- Phase I, II and III clinical studies, FDA Review, Phase IV research
- Project Management
- Compliance, Audit and Validation
- Safety & PV
ALTEN Calsoft Labs offers Life Sciences companies (Pharma, Bio-Tech, Medical Devices) with full cycle post-marketing vigilance and safety in Phase I to IV, and post-marketing clinical studies across a wide range of therapeutic domains.
ALTEN Calsoft Labs’ domain, technology, and functional consultants work with global customers to provide services that meet client’ strategic and operational goals. Leveraging a strong focus on compliance, technology, medical/pharmacological analysis, we are strategically positioned to provide enterprise IT, digital, talent and workforce solutions to our customers.
- AE Collection and Follow up
- Case Processing
- Report writing
- Report development
- Proactive Pharmacovigilance
- Knowledge Services
- Statistical Analysis & Reporting
- Population Studies
- Pharmacoepidemiologic assessment
- Pre-marketing, Post-marketing clinical trials
- Medical device vigilance
ALTEN Calsoft Labs provides comprehensive Regulatory services encompassing drug development, registration, and commercialization. We deliver advisory and consulting services for new drug and marketing authorizations (licensing, registration and approvals), submissions, post approvals to help companies maximize commercial potential and success.
With 20+ years of experience in NDA/BLA/PMA, FDA/EMEA and PMDA submissions, successful industry-academia relationships and FDA working groups collaboration, we are helping Global 1000 and Fortune Life Sciences, Pharma, Bio-Tech and Medical devices companies with services across the regulatory value-chain; encompassing Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval, Legacy Product support/sustenance and labelling.
- Medical Writing
- Clinical Trial Audit & Monitoring
- GxP auditing and best practices
- Submissions management, Labelling
- NDA/BLA/PMA submission
- Digital assets/documents management, Master data management
- CTD / eCTD formats, variations, renewal
- Active Substance Master File (ASMF) variation files, certificate of suitability (CEP)
- Quality Overall Summary (QOS)
With the commitment to quality and stellar execution experience, we craft tailor made audit programs aligned to address unique risks and needs of life sciences organizations.
- Clinical Audit (investigator sites, CROs, PV System audit)
- QC on Regulatory submission docs
- Drafting and revision of processes and procedures
- Quality support for the operations team
With digital disruption reaching far beyond imagination, ALTEN Calsoft Labs is poised to help Life Sciences leverage enterprise data to deliver a connected patient experience and beyond the pill outcomes.
- 20+ years of Healthcare & Life Sciences experience
- 1000+ Functional and technology consultants
- 220+ SAS consultants – 80% SAS certified
- 9 of Top 20 Life Sciences companies as customers
- 4 of Top 10 Medical Devices
- 12 Fortune 100 customers
- Power of 3 – Enterprise, Digital & Talent/Workforce