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TrialDocsClinical Research Document Management
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contents1. Overview
2. Leadership Profile
3. e-TMF
4. e-Archive
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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
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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
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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
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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
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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: [email protected]
Clinical Operations Enquiries: [email protected]
www.trialdocs.com.au