Scalable Clinical Data Standards delivered on time
Trusted support for Sponsors & CROs — Biostatistics, Statistical Programming, and CDISC SDTM/ADaM with regulatory-ready outputs and disciplined execution.
Standards
SDTM • ADaM • Define.xml
Outputs
TLFs • CSR • Submission
Delivery
Review cycles • SOP checks
Services built for Sponsors & CROs
Specialized biostatistical consulting and programming services supporting pharma R&D with SOP-driven execution.
Quality, compliance & delivery — built into every engagement
We combine domain expertise, strong SOPs, and consistent delivery to help pharma teams meet timelines and regulatory expectations.
Focus
Submission-ready outputs
Approach
SOP checks & traceability
SOP-driven execution
Defined processes with documented checks to maintain accuracy and consistency.
Regulatory-ready outputs
Submission-quality TLFs, packages, and documentation aligned to expectations.
On-time delivery
Clear planning, efficient communication, and predictable timelines.
Client-first collaboration
Transparent updates and proactive support across the engagement.
Results that build confidence
A snapshot of the scale and consistency of our delivery.
Healthcare Domain Clients
CDISC Standardizations
In-Vitro Projects Delivered
Clinical Domains Supported
Need reliable support for your next submission?
Share your requirement and we’ll respond with a clear plan, timelines, and an engagement approach.
Trusted Collaboration
Supporting teams across clinical research & regulatory delivery
We work seamlessly with Sponsors, CROs and cross-functional teams to deliver regulatory-ready outputs.
Clinical Programming
Reliable delivery for analyses, TLFs and submission-ready outputs with review discipline.
CDISC Standards
SDTM/ADaM implementation with traceability, define.xml and reviewer-ready documentation.
Validation Support
Validator-friendly datasets and clean reviewer guides aligned to submission expectations.
Delivery Confidence
Predictable timelines, fast clarifications and structured review cycles to avoid surprises.
Regulatory Mindset
Documentation, SOP alignment and secure execution patterns for regulated work.
Partner-Friendly
Transparent collaboration with Sponsors, CROs and functional teams across the engagement.
Testimonials
What partners value in working with us
Sample testimonials (placeholders). Replace with verified client feedback when available.
Regulatory Affairs Lead
Mid-size Pharma
“The team’s documentation and output quality were consistent, and timelines were clearly communicated. Deliverables were submission-ready with minimal iterations.”
Data Management Manager
CRO
“They handled SDTM/ADaM mapping cleanly with strong traceability. Reviews were smooth and the team was proactive in resolving queries.”
Biostatistics Director
Biotech
“Very collaborative and disciplined execution. The delivery was aligned with our standards, and communication was clear throughout the engagement.”
Want a reliable partner for biostatistics, CDISC, and programming delivery?
FAQ
Common questions
Quick answers to help teams evaluate engagement, timelines, and deliverables.
What services do you offer? +
Biostatistical consulting, statistical programming, CDISC SDTM/ADaM implementation, TLFs, SAP support, integrated analyses, and in-vitro statistics.
Do you support CDISC SDTM and ADaM? +
Yes. We support SDTM/ADaM conversions, define.xml, reviewer guides, validation support, and traceability workflows.
How do you ensure quality and compliance? +
Our delivery model is SOP-driven with structured reviews, documented checks, secured workflows, and consistent communication.
What is the typical engagement timeline? +
Timelines depend on scope (domains, number of tables/listings/figures, standards, and review cycles). After an RFI, we share a clear plan and estimated delivery schedule.
Do you sign NDAs and follow data security practices? +
Yes. We support NDA execution and follow secured access practices for client data depending on project needs and hosting requirements.
How can we get started? +
Submit an RFI or contact us with your requirements. We’ll respond with a structured approach, timeline, and engagement model.
Get in touch
Share your requirement
Tell us what you’re looking for and our team will respond with a plan, timelines, and next steps.
Fast response
We typically acknowledge within 1 business day.
Clear scope
We align on deliverables, standards, and review cycles.