Our Services
Biometrics Services
Robust statistical & programming capabilities for accurate, compliant trial outputs.
Clinical Data Engineering – standardize & integrate multi‑source datasets (EDC, labs, imaging, devices).
Programming & TFL Generation – end‑to‑end SAS/statistical programming for submission‑ready tables, figures & listings.
Process Improvements – automation, reusable libraries, and AI‑assisted QC to reduce cycle time and defects.
Clinical Data Management
Full‑spectrum services to maintain integrity, consistency, and readiness of trial data.
Database Build – design & deploy study databases aligned to protocol and SDTM/controlled terminology.
DTA/DTP – define and govern vendor/system data transfers, schedules, and validations.
Data Consolidation – unify EDC, labs, imaging, wearables into a submission‑ready environment (SDTM/ADaM).
Clinical Systems Management
Implementation, integration, and governance for modern clinical platforms.
EDC – configuration, validation, and support for leading platforms with risk‑based approaches.
CDR – centralized clinical data repositories for integrated, standardized, and trusted study data.
SCE – secure, scalable statistical computing environments for programming, analytics, and submissions.
Why Spotline?
Domain Expertise
Automation‑First
Submission Readiness
Scalable Delivery
Quality by Design
Secure & Compliant
How We Deliver
A proven framework that meets your teams where they are, integrates with your tools, and accelerates time to insight and submission.
.png?width=512&height=512&name=1%20(1).png)
Discover
Workshops, protocol & source review, architecture & plan.
Design
Standards, models, flows; build plan & validation approach.
Build
Database, mappings, pipelines, SCE; code & automate.
Operate
Ongoing DM, programming, QC, monitoring, continuous improvement.
Case Studies
Revolutionizing Compliance Data Summarization with ML-Driven Analytics
In the dynamic landscape of the Life Sciences industry, regulatory and financial reporting forms the crux of communication with regulatory bodies and stakeholders. These reports encapsulate critical findings from research studies, including clinical trials, thereby conveying vital information.
Learn more
A Seamless Digital Transformation Journey with a Leading Pharma Company
Discover how a leading pharma company enhanced their operational efficiency with the aid of Spotline’s managed services. Facing challenges in scalability, compliance, and system management in the competitive pharmaceutical landscape, The Pharma company sought a robust solution. Leveraging a hybrid model with extended support hours and industry expertise, the Spotline team transformed Pharma company's IT infrastructure
Learn more
Insights
Article
Life Sciences Project Management Excellence
The Spotline Insights on Project Management Excellence are a series of articles targeted at Life Sciences individuals like yourself. They are crystallized from decades of experience of our senior principals who led and managed complex projects across leading Life Sciences companies such as Abbvie, Amgen, Allergan, GSK, and Gilead Sciences before joining Spotline.
Learn More
Article
Using MS Teams to Manage IT Projects – Part 1
Discover the second installment of Spotline's insightful series on utilizing MS Teams to streamline IT Project Management. This segment deep-dives into the integration, planning, and organization features of MS Teams that can remarkably enhance project productivity and communication. Learn about various integration capabilities with applications and active directories
Learn More