IND Readiness Check

Have you just been told to prepare for an IND? Are you sprinting toward clinical trials at a nerve-wracking pace? Are you fielding tough questions about FDA Title 21 CFR Part 11, HIPAA, or GxP?

There's nothing worse than that gut wrenching feeling knowing that you'll soon be under more scrutiny and you just aren't 100% sure your cloud workload is up to snuff. We're here to help! With our technical expertise in Life Sciences and drug discovery, we understand the unique challenges you face as you work to secure your workload ahead of clinical trials.

With an IND Readiness Check, Tennex will:

• Host a deep-dive session to talk through common concerns and pain points when securing workloads on AWS
• Share some AWS best practices, as well as our own hard-won tips and tricks learned from direct industry epxerience
• Review your workload, and offer prescriptive guidance specific to your environment and needs
• Identify any potential pain points, and share some ideas to get you to success

Let's work together to ease the anxiety, identify the gaps, and enable your organization to confidently pursue clinical trials.

An IND Readiness Check is designed to identify gaps in your cloud security posture prior to IND submission or formal audits.

Step 1. Introductions: Tennex will conduct a quick discovery call to get an understanding of where you are today and where you want to go. In this meeting, we will ask about your roadmap, pipeline, and technology platforms.

Step 2. IND Readiness Session: A Cloud Architect will conduct a meeting (up to an hour) with your key stakeholders to better understand your specific concerns, share best practices and prescriptive guidance, as well as brainstorm solutions to particularly hairy problems. Note that Tennex cannot perform any hands-on keybaord work as part of this discussion.

Step 3. Recommendations Session (Optional): Based on the topics and priorities outlined in the strategy session, we will meet for 30 minutes to discuss the next step recommendations or add additional time for topics needing further research or a direct collaboration with Tennex.

Following the IND Readiness Session, you'll receive a detailed summary of our conversation, along with relevant AWS or third-party documentation for your review. Should we identify an opportunity for a broader collaboration, Tennex will share an SOW with rough pricing as well.

We'll handle everything, and reach out to schedule our session as quickly as possible.