Rob Nichols, DATATRAKGeneral Manager Europe,

VP Global Corporate Development

Cloud Computing for the Clinical Environment

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Agenda

► What is cloud computing► Cloud computing for the clinical environment

• Value add

• Good practice

► Moving the TMF into the cloud► What are the regulators making of eTMF

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What is Cloud Computing?

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How Many Clouds Are There?

Are they connected?

Or not?

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Are They All The Same?

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What Could Go Wrong?

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Cloud Computing – A Definition

WikipediaThis article may be too technical for most readers to understand.

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Cloud Computing – A Technical Definition

► “Cloud computing is a model for enabling ubiquitous, convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction.”

---National Institute of Standards and Technology (NIST) U.S Department of Commerce

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Cloud Computing – A Simple Definition

► “The practice of using a network of remote servers hosted on the Internet to store, manage, and process data, rather than a local server or a personal computer.”---Oxford English Dictionary

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Essential Cloud Components► On-demand Self-service

• Acquire computing capabilities as needed, without human interaction or support

► Available Everywhere• Access is provided through standard mechanisms any

time, – Minimal system downtime

• Anywhere, on any device – Mobile phones, tablets, laptops and workstations

► Dynamic Computing Resources• Computing resources are pooled to serve multiple

consumers using a multi-tenant model, with different physical and virtual resources dynamically assigned and reassigned according to consumer demand.

– Examples of resources include storage, processing, memory, and network bandwidth.

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Cloud Computing is Everywhere

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Flavours of Cloud Computing

On PremiseApplication

Admin

Application / Data

Database

Middleware

O/S

Storage

Servers

Networking

Power and Cooling

IaaS

Application Admin

Application / Data

Database

Middleware

O/S

Storage

Servers

Networking

Power and Cooling

PaaS

Application Admin

Application / Data

Database

Middleware

O/S

Storage

Servers

Networking

Power and Cooling

SaaS

Application Admin

Application / Data

Database

Middleware

O/S

Storage

Servers

Networking

Power and Cooling

At the point of purchase:

–SaaS (Software as a Service)

–PaaS (Platform as a Service)

–IaaS (Infrastructure as a

Service)

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How Many Clouds Are There?

Are they connected?

Or not?

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Are They All The Same?

Public

Private

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What Could Go Wrong?

Is it always connected?

Is it safe/secure?

Is it validated?

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Cloud Computing for the Clinical Environment?

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Cloud-Based Technologies open a whole new world

for Clinical Trial Management

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eClinical Cloud-Based Value Add

► Single Database Architecture - All parts of eClinical platform sitting on a single cloud

• Single interface and password

• Access from anywhere, anytime

• Single joined up picture – no migration of data between systems and no cost of integration

• Built to make changes (e.g. mid-study protocol amendments) without taking the system down

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eClinical Cloud-Based Value Add

► Real-Time Study Management across all data

• Study Dashboards – data trends, monitor quality

• Reports – standard and adhoc

• Remote Data Review & Monitoring

► Real-Time System Responses

• Notifications for Serious Adverse Events

• Drug Supply

• Create across data quality scores and drive RBM

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eClinical Cloud-Based Value Add

► Support relationship management with CRO and sites• Move away from time based unit of

measurements to activity/task based measurement

• Can see average time to task - e.g. Data Entry within 48 hours of visit

• Payments based on data quality (no queries or open issues)

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Essentials for Cloud-Based Clinical Applications

► Enterprise Class Security

• Support for current security standards–PCI DSS, HIPAA, HITECH and SOC 2

• Self-service administration

► Disaster Recovery & Business Continuity

• Ability to maintain availability to serve your business

• Redundant sites, hardware and networks

• Verified business continuity plan

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Essentials for Cloud-Based Clinical Applications

► Availability & Uptime

• Redundancy to provide users with limited down-time– Designed to be upgraded while online– No down-time for mid-study changes

► Validation

• Ensure consistent on-going performance, security and integrity of stored and managed data

• Comply with regulations including the movement of data between geographical areas

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Moving eTMF into the Cloud

► Start to provide the study team, auditors and regulators with the same cloud value add by getting supporting documents available in real time

► Help meet regulatory requirement that the TMF should be be up to date or complete, well structured, date ordered, indexed and documents in it should be complete, signed and dated (where applicable) and legible.

► Provide regulators with the direct access they require

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Regulatory Learnings

► TMF may now be paper and eTMF and other electronic systems

► Training in systems must be simple (<1hr)► No current plan to access remotely

=> The shift from paper to electronic is understood but regulations still apply – make sure they are considered as you make the move to eTMF

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Summary

► The cloud is well established in many areas of day-to-day life.

► The key features can provide rich benefits when running clinical trials.

► While there are some regulatory concerns, the eTMF can also benefit from a move to the cloud (as the next presenters will focus on).

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Appendix

► Full set of MHRA slides

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Maintenance of the TMF

► EU Guidance (TMF1, GCP2) covers filing in a timely manner, indexing, use of electronic media etc.

► Essentially, during the trial and afterwards, the TMF should be up to date or complete, well structured, date ordered, indexed and documents in it should be complete, signed and dated (where applicable) and legible.

1. Recommendation on the content of the trial master file and archiving July 2006

2. CPMP/ICH/135/95: “Note for Guidance on Good Clinical Practice” (ICH E6)

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Provision of the TMF for Inspection

For UK inspections of UK trials, inspectors may require you to provide for inspection:

►Sponsor TMF relating to UK investigator site (site Level), files with UK relevant documentation (country level and trial level)

►Specific sections of the TMF or all of it (dependent upon the scope of the inspection)

►For contracted out trials (where TMF is managed bythe CRO), the sponsor’s “oversight files” would be required instead of/in addition to the CRO’s TMF dependent upon inspection scope and trial status

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Provision of the TMF for Inspection

Direct Access is an inspector’s right, however, issues with “Hybrid TMF” (paper/eTMF (formal eTMF plus one or more electronic systems))

►Direct Access to primary eTMF system or Paper Files is expected (this is often the organisation’s perception of what the TMF is).

Access to a certified copy (sponsor would have to demonstrate that this is an accurate and reliable copy) may be acceptable to the inspector.

►Direct Access to other systems that contain TMF documents (often the organisation is unaware that these are part of the TMF) is expected. Access via a system user, access to a certified copy (sponsor would have to demonstrate that this is an accurate and reliable copy), or by specific document request may be acceptable to the inspector.

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Provision of the TMF for Inspection

► The organisation should discuss the provision of the TMF (or specific sections) with the Lead Inspector when the inspection is being planned:

• Organisation should know what the TMF is and where all of its documents are located

• Should have formal processes to define, manage and control the TMF

• Should decide how the TMF will be provided to the inspector in accordance with the regulatory requirements

► Failure to meet the requirements agreed duringthe planning is NOT acceptable

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Inspection of TMF

► As part of the planning process the inspector will now ask for indices and SOPs/Plans for the TMF for the selected trials.

► Inspection plans already have statements regarding the TMF provision

► Training in an electronic system should not be more than 1 hour (could happen prior to inspection)

► MHRA Inspectors do not have to sign any document (aside from site/facility access badges/sign in) at an inspection

► MHRA Inspectors are not required to follow organisation’s SOPs/Policies relating to accessing the TMF

► Currently not inspecting TMF remotely – no plans to change this

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Summary► Organisation’s responsibility to meet regulatory requirements for

provision of the TMF, failure to do so is likely to result in:

• Major/Critical findings• Termination of inspection and revisit• Additional days fees

► Whilst we appreciate there is a change from paper to electronic systems in clinical trials, compliance with regulatory requirements is still necessary at all times

► Inspectors aim to clarify and agree with organisation prior to the inspection, how and what will be required for the TMF inspection, however, during the inspection it may be necessary to change this dependent upon what is found.

► The commissioning of new eTMF systems by an organisation should include regulatory requirements as part of the specification of the functional/user requirements.

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