Guidance for Emerging Life Sciences Companies
Early-stage life sciences organizations face many challenges, but planning and implementing IT doesn’t have to be one of them. This on-demand webinar shows you powerful tools and techniques to help you set priorities and confidently make business decisions. Follow key principles and techniques to ensure you make the right investments at the right time with partners that are the best possible fit for your organization. Learn how to build a strategic IT roadmap, define roles and responsibilities, and establish processes to make successful software investments.
Watch on-demand to rethink your challenges and develop an IT strategy that scales from the pre-clinical phases through commercialization.
What You’ll Learn
- How to build a strategic IT roadmap that includes critical regulatory and functional requirements and milestones.
- How to understand the business needs and drivers behind G&A and GxP functional areas.
- How to make timely, scalable IT investments at the right time for your stage of growth.
- How to establish or harmonize an IT compliance program that fuels growth while addressing cybersecurity and privacy needs.
- How resourcing models—fractional CIOs, managed services, and staff augmentation—help you efficiently achieve business objectives.
What We Discussed
- Building a strategic IT roadmap that includes critical regulatory and functional requirements and milestones
- Understanding business needs and drivers for G&A and GxP functional areas
- Making timely and scalable IT investments
- Establishing or harmonizing an IT compliance program to fuel growth
- Addressing cybersecurity and privacy needs
- Resourcing models—such as fractional CIOs, managed services, and staff augmentation—to efficiently achieve business objectives
- Case studies for rapid growth and transformation
Why this matters: For emerging life sciences companies, IT decisions made early shape how quickly—and how compliantly—you can scale toward commercialization. Treating IT strategy as a planned roadmap rather than a series of reactive purchases helps you keep regulatory requirements in step with business milestones, build an IT compliance program with a right-sized validation approach such as computer software assurance, and invest in the right capabilities at the right time. Because much of an emerging company's roadmap runs on outside partners and managed services, choosing the best-fit providers—and applying third-party risk management to those relationships—is part of building a strategy that grows with the business.
Watch the On-Demand Webinar
Watch the video below to see a preview of the discussion. >> Fill out the form and click Watch Now to access the full-length on-demand webinar.
In this highlight video, see a sneak peek of Roger Davy discussing important cost-effective strategy and planning considerations.
Presenters:
Erin Christy, VP of Emerging Life Sciences and Clinical Solutions
Erin focuses on helping start-up biotech, pharma, and medical device companies accelerate their commercialization journey and establish their IT and regulatory compliance strategies. She has over two decades of experience in life sciences GxP applications, business relationship management, regulatory compliance program management, and IT strategy development.
Roger Davy, Director of Customer Engagement
Roger has over 20 years of experience in consulting and industry roles in the pharma, biotech, engineering, and semiconductor industries. Working with small and large life sciences firms, Roger leads professional services teams to deliver transformative compliance, technology, and cybersecurity programs. Roger helps his emerging life sciences clients by implementing cloud-based enterprise IT solutions, supporting successful regulatory submissions and inspections, and managing post-acquisition integration programs.
Hovsep Kirikian, Director of Product Management
Hovsep leads USDM’s Veeva practice and has over 15 years of experience managing projects in the life sciences industry, specifically focusing on regulatory compliance, validation, equipment lifecycle, laboratory operations, and data and content management across all phases of the product life cycle.
Frequently Asked Questions
Who is this on-demand webinar for?
It’s designed for early-stage and emerging life sciences organizations—biotech, pharma, and medical device companies—that are planning and implementing IT from the pre-clinical phases through commercialization.
What is a strategic IT roadmap and why does it matter?
A strategic IT roadmap maps your critical regulatory and functional requirements and milestones over time, so you can make timely, scalable investments and align technology decisions with business needs across both G&A and GxP functional areas.
How do resourcing models help emerging companies?
The session covers resourcing models such as fractional CIOs, managed services, and staff augmentation, which let emerging organizations efficiently achieve their business objectives without over-building internal teams before they’re ready.
Does the webinar address cybersecurity and privacy?
Yes. Building or harmonizing an IT compliance program includes addressing cybersecurity and privacy needs as part of a roadmap built to fuel growth.
How can I get help with my IT strategy?
After watching, you can contact USDM to discuss a compliant IT strategy tailored to your stage of growth and commercialization goals.
Ready to watch? Fill out the form above and click Watch Now to access the full-length on-demand webinar, or contact USDM to talk through your IT strategy.