Implement Software Solutions that Support and Enhance Your Mission
At Sikich, we empower life sciences organizations through strategic planning, regulatory expertise, and digital modernization. From inception to commercialization, we specialize in planning, regulatory, quality, and compliance, leveraging cutting-edge technologies like Oracle NetSuite, Kneat Gx, and Honeywell’s TrackWise Digital, to streamline operations and accelerate innovation.
Our tailored approach combines deep industry knowledge with advanced digital tools, ensuring compliance, enhancing efficiency, and reducing time-to-market for life-changing therapies. A focus on built in audit trails, roles-based control and automated reporting ensure compliance with FDA 21 CFR Part 11, SOX and EU Annex 11. With a commitment to precision, integrity, and transformation, we help companies navigate complex regulatory landscapes and embrace the future of life sciences with confidence. Plan smarter. Modernize faster. Innovate with impact.
Your End-to-End Implementation Partner from Discovery to Delivery
SuiteSuccess for Life Sciences
Progressing through clinical trials, evaluating or planning an IPO, all while undergoing rapid growth have a unique set of financial, contract, compliance, and reporting needs. SuiteSuccess for Life Sciences with NetSuite enables you to advance your research throughout every stage of your business life cycle.
SuiteSuccess for CROs
Shorten start-up times for your clinical research studies by eliminating manual spreadsheets once and for all. SuiteSuccess for contract and clinical research organizations (CROs) allows you to unify clinical applications to improve visibility and oversight across the organization in one software platform.
IT Quality & Compliance for Life Sciences
Life Science organizations are successful with our custom-tailored range of services for growth and innovation. From software validation, Laboratory Equipment/instrument validation, testing services to navigating GxP Services such as U.S FDA and EU regulations, we help our customers navigate a path forward as they embark on their digital transformation journey.
QMS for Life Sciences
Find out why nearly 275 life science companies have chosen SuiteSuccess for Life Sciences, built on NetSuite, to focus on what they do best: developing new treatments for patients who need them. We empower life sciences companies with the tools, expertise, and strategies, guiding them through every stage of their journey.
ArchiveIQ
A validated archive tool that simplifies moving and archiving data out of TrackWise® into an enterprise repository or into archiveIQ’s Repository System. It’s built-in data archiver schedules jobs to extract data out of TrackWise, and offers a user-friendly data repository system to allow for viewing, querying and reporting on archived data.
MigrationIQ
An automated solution that simplifies the data migration process. The point-and-click tool streamlines the process of extracting, importing and validating your data, and has data capture functionality for file attachments and audit trail reporting.
Life Science ERP Built on NetSuite
See why nearly 290 life science companies have chosen SuiteSuccess for Life Sciences, built on NetSuite, to focus on what they do best: developing new treatments for patients who need them.
Discover MoreERP and IT Management for Regulated Environments
We deliver ERP services from selection to post go-live support, ensuring secure, validated, and connected operations. These systems often serve as the backbone of digital transformation, enabling Life Sciences companies to streamline workflows, unify data, and scale with confidence. Our IT services cover cloud infrastructure, vendor oversight, cybersecurity, and system integration tailored for FDA-compliant operations and complex global environments.
Scaling operations, managing compliance, and preparing for commercialization require systems that work together and adapt fast. With experience supporting more than 290 Life Sciences organizations, Sikich brings proven strategies to every ERP and IT engagement to support growth and meet FDA expectations.
Business Intelligence and Enterprise Performance Management
We implement dashboards, forecasting models, budgeting tools, and enterprise performance management (EPM) solutions that give teams the ability to evaluate tradeoffs, align resources, and act on insights with speed and precision. Whether you’re tracking trial costs, managing budgets across programs, or preparing for board reporting, our tools turn disconnected data into actionable strategy.
Disparate systems and siloed data delay critical decisions and reduce visibility across the business. Sikich designs analytics and performance environments that integrate financial, clinical, operational, and quality data into a single source of truth.
Quality Management and Compliance
Disjointed quality processes and outdated systems can slow audits, increase risk, and limit scalability. Sikich builds modern Quality Management System (QMS) environments that streamline documentation, automate critical workflows, and improve traceability from early stage through commercialization.
Our team configures AI-enabled platforms, executes validated data migrations, and aligns each implementation with GxP requirements. We offer end-to-end digital compliance services, including computer system validation, risk-based assessments, SOP development, remediation planning, role-based training, and GMP alignment. Each solution is designed to protect data integrity, ensure inspection readiness, and evolve with your regulatory landscape.
