TrialDocsClinical Research Document Management

2

1

contents1. Overview

2. Leadership Profile

3. e-TMF

4. e-Archive

A

01

3

OverviewTrialDocs is a Clinical Trial Document Management

Company, established in Pharmaceutical and CRO

expertise, and expansive Trial Master File content

knowledge. TrialDocs have end-to-end content

management solutions, which includes e-Archive

and e-TMF focused at Site content.

Over 15 years biopharmaceuticalexperience and 25 years sales andmarketing expertise

5

Clinical Research Principal – Allan BukuyaAllan Bukuya is trained in Pathology Science (BSc.

M.L.S), operating through some of Australia’s key

teaching hospitals. Allan’s extensive Biopharmaceutical background spans 15 years, starting out in Senior Sales roles, collaborating with key General Practitioners, Endocrinologists and Cardiologists.

Allan transitioned to clinical research, profoundly

impacting development of trials in Europe during

the induction period of the EU Directive for Clinical

Trials. During this time, key strategies with unique

perspective were developed by Allan to influence

typical milestones of trials, such as start-up

timelines and recruitment.

While ensuring compliance with clinical trial

regulations and establishment of the necessary

documentation, tremendous change was influenced

on trials which were historically quite challenging,

for example gene therapy.

Allan has seen terrific results through his clinical

solutions approach and has supported electronic

solution implementation through every one of his

past companies.

Bringing vast clinical research experience at

both Biopharmaceutical and Contract Research

Organisations, Allan brings essential and critical

knowledge of trial execution and also clinical

project management gaining experience across

multiple global regions.

Established experience in clinical operations

management within global leading organizations

and regional leadership of electronic clinical

solutions, founding tremendous leadership of

this innovative technology. Advanced knowledge

and innovative perspective fuels this technology

enhanced by knowing the expectations of electronic

trial master files and clinical quality requirements

for electronic medical records.

Business and Marketing Principal – Wayne RichardsWayne Richards is qualified having gained a Bachelor

of Commerce Degree and Majoring in Marketing

(Hons). He is a Fellow of the Australian Institute

of Management.

Wayne has 25 years experience in holding prominent roles in the capacity of President and Director of Sales and Marketing roles for both ASX registered Corporations and Privately owned companies both Internationally and in Australia. Wayne has also

sat on various Boards as well in his capacity as the

Principal of the Sales and Marketing Divisions.

Wayne has created Business and Marketing strategies

for Coca-Cola worldwide, Brightpoint Inc one of the

largest Telecommunications Distribution companies

in the World, Fosters Group, Carlton United, Roche,

Budweiser, Bass, Coors, Asia Pacific Breweries and

created Privately owned Corporations one of which

was pivotal in the establishment of the Market in

Information Kiosks that have been utilised in Major

Retailers such as Coles Supermarkets Australia wide,

Liquor Land, Noodle Box and other Retail Franchises

along with the ALH Group of Hotels. This company

was sold to a private equity company for $10.7

Million and is now progressing to build its market

share Worldwide under the original name.

He has also been the Key Consultant in developing

relationships between the Russian and Chinese

Power Brokers in signing off on some of China’s

Major Commodities and Resources Transactions.

He was CEO of a large Commodities and Resources

Company and still consults to this Dynamic Market.

Wayne today runs his own Business and Marketing

Consulting firm advising Publicly Listed and Private

ventures with commercial interests throughout

Asia, Europe, US, Russia, Middle East, New Zealand

and Australia. He brings a Wealth of knowledge

to this Clinical Research Technology through his

Business Relationships and Networking abilities

throughout the Private and Government Channels.

Leadership Profile 02

TrialDocs streamlines paper management processes, reducing costs and vastly improving quality

6

e-TMF 03TrialDocs’ e-TMF is a Site focused end-

to-end content management solution,

designed to enable true remote

monitoring of trial documentation.

Our e-TMF is CFR Part 11 compliant,

intelligently programmed, based on

document relationship, indexed according

to both TMF Reference Model and Sponsor/

CRO table of content. To support 100%

Audit and Inspection Readiness, you will

know the content of your site file, but, as

important, you will know what is not yet

available in your file.

Improve start-up timelines and document response times

8 A

Text Analytics Unstructured and structured text analysis entity identification, concept extraction.

Ontology and Rule Systems Models information relationships and applies validation rules - for example, document submissions to the Ethics Committee will require a corresponding approval from the HREC.

Authorisation and Access Control

Ensure only pre - authorised people can access the relevant trials, documents, and sections, and the audit trial capture all CFR Part 11 compliance requirements, document and trial changes.

Logical Information and Document Model Mapping Capability

Maps & transforms information elements and documents from logical directory structures into nominated external systems like internal pharmaceutical company tables of contents

Trial Workflow Management System

Manages all aspects of trial operations - supports all trial modifications, interacts with nominated staff to inform them of updates and required document inputs, trades validation of contents, and on success moves on to the next trial activity.

Document and Information Control

Understands the necessary documents on a sponsor/trial basis and modifies its workflow to suit changes dynamically.

Doc Dependency Management and Content Validation Capability

Uses rules to understand the impact of changes on document elements dependencies.

Optical Character Recognition (OCR)

Analyses scans of unstructured or structured, docs and applies OCR & text analytics to identify the key entity’s & concepts like names, places, things, attaching them as metadata tags to the scans.

Linked Data Validation Module

Applies rules to provide higher-level validation of correct and consistent information entry.

Auditing ApplicationsSupport system operations, and external access to validate documents, the relevant information sections, and the audit trail changes related to the trial.

Document, Clustering, Cross-reference & Search

Providing conceptual search understanding of both the related documents elements, and authorised staff and locations - to provide an effective trial tailored search.

Managed Service Platform Web hosting platform for portal/user applications audit & reporting services, and short-term information storage.

Long Term Document Archival

Transitions trial content from/to long-term archive.

Portal User Application Framework

Supports adaptive user interface user access & authorisation and integrates with the trial management workflow.

System Components

a simple intuitive interface enables users to effortlessly navigate the software

TrialDocs reduces costs, improves effi ciencies and simplifi es the clinical trial process

12

e-Archive

04TrialDocs would execute this e-Archive by

ensuring the scanned electronic version

is a certified copy; indexed according to

the project table of content , standard

naming convention, and further tagged

according to the TMF Reference Model,

to enable simple electronic document

locating. The documents would be

filed according to the table of content

structure and stored (and backed-up) per

secure Cloud Storage.

Any required original documents would

be collected by Sponsor/CRO Monitor

leading up to the point of Trial Close-Out

visit. As a Site, we would maintain hard-

copy documents such as Clinical Trial

Agreements, Indemnity Agreements and

Subject ID Logs. The electronic content

(post e-Archive) will be reviewed against

the hardcopy Files to ensure an accurate

transfer is complete, but thereafter

the remaining hard-copies would be

confidentially destroyed.

The electronic archive process offers

a sensible electronic solution, no

requirement of physical space and the

most cost effective means of Investigator

Site File Archival. It is imperative that

the e-archival is executed after the final

database lock and once the Monitor

has collected from Site all required GCP

Essential Documents and related content.

In case of a Sponsor Audit or Regulatory

Inspection, restricted access to content

will be provided, upon official request.

In line with Good Clinical Practice, local and global regulation, and related guidelines, the hard-copy documents are transferred and imbedded to electronic files (PDF/A), ensuring content integrity and maintaining the accurate and complete representation of its hard-copy version.

TrialDocsClinical Research Document Management

Business Enquiries: waynerichards@trialdocs.com.au

Clinical Operations Enquiries: allanbukuya@trialdocs.com.au

www.trialdocs.com.au