Streamline FDA Compliance in Clinical Trials Playbook

© 2021 All Rights Reserved | www.egnyte.com
Streamline Compliance in
Clinical Trials
Campaign Playbook
6/2021

© 2021 Egnyte Inc. All Rights Reserved. | Confidential | www.egnyte.com
Agenda
01 What’s in it for an MSP
02 Campaign Abstract
03 Goals & Objectives, Key Business Drivers
04 Target Audience
05 Campaign At A Glance
06 Roll-out Plan
2

What’s in it for an MSP?
• A campaign playbook to quickly ramp up with an
Egnyte for Life Sciences lead generation program
• Quickly and easily access co-branded templates to
execute a targeted lead generation program
• Quickly increase awareness and interest in the
Egnyte for Life Science solution within your life
sciences installed base
• Drive leads, build sales pipeline and, ultimately,
sales revenues

Campaign abstract
With over 50% of clinical trials being outsourced through global CROs, and 65% of R&D activities outsourced,
this poses a serious challenge to life science companies. Collaboration and compliance are essential to
keep biotech innovating.
Many clinical trial leaders struggle with managing data-related risks across a fragmented set of repositories
on-premises, and in the cloud. Traditional solutions are inadequate to maintaining a GxP and FDA 21 CRF
Part 11 compliant environments. Further, there are security risks with exchanging data with external global
partners.
For smaller organizations who have limited IT resources, the implications of FDA fines and penalties can be
disastrous. With Egnyte, you can be confident that if the FDA comes calling, your quality team can say we
have the right policies in place to ensure compliance.

Goals &
Objectives
Key Business Drivers

Goals & Objectives
• Educate users about key factors driving demand for compliant content governance
• Limitations of traditional solutions
• Why look to utilize a compliant, unified data management platform
• Achieve a GxP and FDA 21 CRF Part 11 compliant environment
• Support data privacy laws (GDPR, CCPA, and more)
• Build awareness of the MSP + Egnyte as experts in compliant content governance
• Drive leads, build sales pipeline and, ultimately, revenues

Key Business Drivers
• Pandemic is accelerating the digital & IT transformation of clinical trials
• Acceleration to adopt technologies to support virtual work
• A move toward decentralized global clinical trials
• IDC projects 90% decentralized trials by year-end
• Concerns around data collection, remote technology
• Regulatory guidance for decentralized trials and data collection
These business drivers are motivating
quality + compliance leaders to
re-evaluate how they manage clinical trials

Target Audience
A look at the life science 3 stages

Target Audience
Small to mid-size life science companies
• Therapeutic companies
• Medical device companies
# of employees: 20 to 200; possibly 201 – 499
Personas
• Quality – Responsible for the overall compliance of the company
• Clinical – Manages the operations and /or data from clinical trials
• IT – Implementation, security and compliant systems
Job titles: (sample)
• Compliance Officer
• Director Clinical Operations
• Clinical Trial Manager

Life Sciences | 3 stages
Early Stage Mid Stage Late Stage
Key focus
area
Pre-clinical
• Research
• Development
• Collaboration
with external
partners
• Little
regulation
Implementing the structure
• Quality docs, SOPs, clinical trials, regulated
manufacturing
• Exchanging data w/ external CROs, CMOs,
consultants
• File sharing, standard collaboration
• Archiving SOPs, GxP data in compliant 21
CRF Part 11 repository
Completed trials, drug doing well
• Exchanging data w/ external partner
• Typically, already has infrastructure
in place
• Unregulated collaboration
Key concern GxP + GCP Data privacy + GDPR compliance
21 CFR Part 11 repository
Initial focus: Data privacy
End with GxP

Campaign At A Glance
A look at each of the 5 touches

• Email follow-up
• Thank you for attending
• +
• Offer ‘Best Practices. 21
CFR Part 11 + GxP
Validation’ WP
• +
• Meeting request
Webinar
Email campaign
‘4 Steps To
Compliant Clinical
Trial Workflows
Email campaign
Offer ‘Data Privacy
in Clinical Trials –
Best Practices Guide’’
Campaign flow at-a-glance
Email campaign
Mitigating biotech
compliance &
security risks
+
meeting request
Email - Webinar
invitation
MSP’s Installed
base +
Prospects db
LinkedIn – Outreach, Messaging
Blog posts
Website posting(s)
Email campaigns
Data Privacy
Regulations
Impacting the Life
Sciences Industry.
www.egnyte.com | © 2021 by Egnyte Inc. All rights reserved.

Topical Webinar
Intent stage: Discovery + Learning
Return on engagement: Information
Title: [Demo] GxP audit trails, data integrity + user access
Agenda (sample)
• Introduction
• Challenges facing therapeutic and medical device companies
• Why existing solutions are inadequate to fix problem
• Leaders look to innovative content governance technology
• Customer case study (optional)
• Egnyte demo – Key features audit trails, data integrity, user access controls
• Q & A

Webinar | Email invitation

Best Practices. 21 CRF Part 11 +
GxP Validation WP
• Recent technological trends
• Specific challenges for Quality & CSV teams
• Best practices for tackling compliance issues
• Use automation
• Build an ecosystem
• Choose the right partner

Email Invitation | GxP Best Practices White Paper

Data Privacy Regulations
Impacting Life Sciences WP
• Global clinical trial hotspots + their data
privacy laws
• CA, NY, Canada, and more
• How to comply with data regulations
• How to mitigate the risk of a breach
• Roles in GDPR-harmonized data privacy
regulations
• How to operationalize best practices
Data Privacy
Regulations
Impacting the Life
Sciences Industry.
www.egnyte.com | © 2021 by Egnyte Inc. All rights reserved.

Email Invitation | Data Privacy White Paper

4 Steps To Compliant
Clinical Trials
Explore 4 key attributes to ensure FDA
compliance
• Audit trails – Ensure your client knows who’s
doing what with each dataset
• Data integrity - Leverage check sums to
validate your data integrity
• User access – Ensure user restrictions
maintain the highest level of data privacy
• E-Signatures – Initiate the review and
approval of regulated documents with
compliant workflows

Email Invitation | 4 Steps to Compliant Clinical Trials

Data Privacy in Clinical Trials
A Best Practices Guide
• Best practices to comply with regulations
• How to audit processes for more than quality
• How to develop SOPs for regulated data
• How to centralize data to minimize risks
• How to automate data governance to minimize risks

Email Invitation | Data Privacy Guide

Measurements /Targets
COVID-19 Impact on IT Spending Survey, where over
32% of healthcare / life science respondents
expected to increase software-as-a-service (SaaS)
spending by more than 10% —
more than any other industry surveyed.
Region - US
Emails sent
Webinar registrations
Actual attendance
Asset downloads
Asset #1
Asset #2
Asset #3
Social media engagement
LinkedIn
Twitter
Facebook
Leads (Sales Qualified)
Sales opportunities
Sales wins

Roll-out Plan
Post campaign lead follow-up

Roll-out Plan
Activities Timelines
Collaboration between Egnyte and MSP
Communication to the sales teams
Social media postings Last week of TBD
Email #1 – Invitation / Webinar [Tuesday, TBD] Drop 1st email 1st week of TBD
Email #2 – TY email + offer GxP WP TBD
Post webinar debriefing Friday, TBD
Email #3 – Mitigating Biotech compliance risks WP Mon., TBD
Email #4 – 4 Steps to Compliant Clinical Trial Workflows Thursday, TBD
Email #5 – Data Privacy in Clinical Trials Tuesday, TBD
Post campaign debriefing Friday, TBD

Post campaign lead follow-up
• Identify the hot and warm leads
• 3 touch follow-up
• Email
• Phone call
• Email

Streamline FDA Compliance in Clinical Trials Playbook

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to Streamline FDA Compliance in Clinical Trials Playbook

Similar to Streamline FDA Compliance in Clinical Trials Playbook (20)

Recently uploaded

Recently uploaded (20)

Streamline FDA Compliance in Clinical Trials Playbook