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International Clinical Trials

Several Contributors – One Document

Kris Sæther and Andreas Jordell at Xait discuss how to keep on top of the workflow when multiple contributors are working on the same document

What are the common characteristics of documents such as clinical submissions, proposals, procedures, manuals and financial reports? Most importantly, they are business critical documents that are published externally or shared internally, making quality of content an essential feature, and installing stringent requirements on availability, accessibility and security.

These are large documents that can span several hundred pages, making them complex to produce. A typical creation process draws resources from every part of the organisation, requiring the collaborative and simultaneous effort of multiple writers. Different personnel are involved in different phases of the creation process, and documents often go through a predefined workflow of review and approval, where responsibility and control is passed from one person to another.

Consequently, many organisations struggle to maintain control. Finalising a document on time and with satisfactory quality is a not a trivial task and requires a great deal of coordination. Confusion often arises. Who is doing what and when will they do it? Which version is the current version and who holds it? Who is responsible for making sure that formatting, layout and numbering is consistent across the document? How are attachments included?

Following its creation, a document and the information contained within must be managed. This may involve publishing, updating, recycling, storing and deleting data. The common term for these activities is ‘information lifecycle management’. With the rapid growth of information, managing it is becoming an increasingly complex task in itself.

Furthermore, today’s global companies are characterised by having organisations spread over large geographical areas. Tasks are assigned across organisational branches, countries and time zones. This only adds complexity to the challenges represented by document production and information management.

Organisations across the globe are starting to recognise that to successfully and effectively produce and maintain their business-critical documents, traditional tools, such as word processors and document management systems, do not suffice, and consequently they are looking for new and more intelligent solutions. Finding the right tool and then implementing it in an organisation is not a trivial task. In this article we explain why organisation should explore the world of document collaboration systems, but first we take a closer look at CROs and their specific requirements pertaining to document production.

CROs: IN SEARCH OF BETTER TOOLS

Production of clinical research documentation is becoming a fastexpanding industry, driven by the growth of biotechnology and the inclination of the pharmaceutical industry to outsource trial management to CROs in order to become more cost efficient.

A key priority is to produce clinical research documentation that is clear and comprehensive, as this allows for faster decision making. The more efficiently the documentation can be produced, the better. Clinical documents and submissions require ongoing review cycles and approvals. The production process must be transparent, with an auditable log of events available. Edit checks are important to minimise entry errors.

At the same time, flexible job options (working from home or part-time employment, for example) are becoming commonplace. With an increasingly flexible workforce, working in different cities, or indeed countries, it becomes increasingly challenging for the company to maintain control of the document production process.

As for proposal documents, Big Pharma now outsources approximately two thirds of its clinical trial management to more than 1,000 CROs around the globe (1). For the CROs, the pressure is on to deliver proposals on time, with excellent quality, in order to win new clients – or retain existing business. A proposal won’t win the business, but can lose it in a heartbeat. This is why it is important that CROs that are aiming to win more business have access to the best equipment in the toolbox.

THE SOLUTION: DOCUMENT COLLABORATION SYSTEMS

Document collaboration systems allow documents to be edited simultaneously by multiple authors without fear of overwriting or duplicating work. Every team member accesses the same instance of the document, eliminating version confusion. Automatic formatting, numbering and layout ensures adherence to corporate guidelines and brand consistency, and allows writers to focus solely on content. Documents can be accessed from any computer through the internet, without any software installation, allowing contributions to be made from multiple locations and organisations. Project managers have complete control of the production process, assigning tasks and setting deadlines, tracking changes and assessing their status. Documents are therefore produced faster, allowing time to improve the quality of content or increase output.

Document collaboration software provides functionality to manage the post-production phases of the document lifecycle. All features are integrated into one system, reducing the total cost of ownership, facilitating high adoption rates among users, and enabling quick time-to-value for the company.

TRADITIONAL WORD PROCESSORS: ESSENTIALLY ADVANCED TYPEWRITERS

A descendant of the typewriter and early text formatting tools, word processing was one of the first office applications for the personal computer. Today, a typical word processor has functionality for text editing, spell checking, reviewing, typesetting and other layout manipulations, creation of images and graphics, and automatic generation of indices, tables of contents, and so on.

As a result of its heritage, the word processor was created for a single writer and their requirements – to make frequent edits in the document as it was developed without other methods of correction. Although a major efficiency improvement in its own right, the word processor was never intended as solution to the collaborative challenges mentioned above. The lack of functionality to support collaboration continues to be a common denominator of most word processing software sold today, from Microsoft Word, the most widely sold word processing system, to OpenOffice.org’s ‘Writer’, the open-source alternative.

A true collaborative writing application includes all the common features of a word processor, but is designed from the ground up, focusing on textual collaboration and workflow – that is the assigning of responsibilities and deadlines to different writers. This helps automate the collective creation process, while removing the inefficiencies often associated with the use of traditional word processors, such as lack of visibility and control, and difficulties with maintaining consistent formatting and layout.

STORING INFORMATION IN FILES IS INEFFECTIVE

File-based storage is an intrinsic property of word processors. The challenge is that files are ineffective repositories for information: as the amount of information stored inside a single file increases, the accessibility and readability of the file is reduced – both from a human and a computer perspective. Navigating a document of 100 pages is tedious. It is not possible to reuse parts of the document without dealing with the whole file. And, as more figures and pictures are added, it is more likely that the software will crash.

Databases are much more effective repositories for large amounts of information, as data is stored across a multitude of small ‘information containers’. The increased granularity is a huge advantage when it comes to features such as accessibility, security and control. Document collaboration software built on top of databases is capable of focusing on the information in its own right, not the file that contains them. It is, therefore, very simple, for instance, to rearrange and reuse information.

DOCUMENT MANAGEMENT SYSTEMS: SHARING & COLLATION SOFTWARE

Vendors of software for document management systems and other groupware systems often claim that their software is a collaborative application. In reality, they are advocating sharing and collation software. Document management systems cannot change the fact that information is stored in files; they simply add an extra layer of information (metadata) and provide control mechanism for accessing these files.

To work effectively in document management systems, teams need to break the main document into sub-documents, assigning responsibilities to each part. Then, each author needs to lock their piece for editing by other writers in order to avoid data loss or duplication of work. This leads to a fragmented and serial process where contributors constantly have to wait for each other’s input. In many cases this is the point where project managers lose control. Towards the end of process, the person responsible for compiling the document needs to collate a variety of files, generate the document, and ensure that the formatting and layout is consistent.

Truly collaborative tools, built on databases, allow for different subchapters of a document to be created and edited in parallel. The latest versions of all sections and subsections are always available and accessible. Multiple writers are therefore capable of working on the same instance of a document at the same time. This reduces interdependence on other team members and the need for coordination efforts.

For managers, this also ensures improved control of the document creation process, providing access to the document as it develops. Rather than keeping information in separate files, as isolated data silos, document collaboration software promotes teamwork in its purest sense, encouraging the sharing of information. As a result, organisations can produce documentation more effectively and efficiently, leaving time to increase output or improve quality.

As illustrated in the figure, traditional word processors and document management systems become inadequate as the number of writers and/or the document size increase. When two or three people collaborate on one document, they can manage quite easily with a word processor and a file sharing system. Conversely, small documents are easy to maintain using groupware. But only document collaboration systems can cater to all combinations.

MAINTAINING SEVERAL SYSTEMS IS COSTLY

Relying on one word processor as an editing environment in addition to one or more groupware systems for access control and search not only increases complexity from a user perspective, but also increases the total cost of ownership (for example licensing, training and maintenance) dramatically. The best document collaboration systems allow organisations to manage the document lifecycle using one system. Users can produce, store, edit, reuse and delete documents from one common user interface.

ENSURE SUCCESSFUL IMPLEMENTATION: BELIEVE IN BAD FIRST DRAFTS

The benefits of document collaboration systems have now been described in detail, and are summarised in Table 1. But after buying and installing such a system, how can a company ensure successful implementation?

From a management perspective, taking control of the document creation process and the ability to monitor progress is ideal – nothing can be hidden. But in organisations that migrate from traditional word processors, writers sometimes express discomfort about sharing their work; they may not want to share their part of the document before it is complete.

This attitude makes it impossible for the rest of the team to comment or monitor the progress of the document, and is a serious threat to any collaborative document creation process. What if a particular section is of vital importance to other parts of the document? To ensure consistency, other writers need to have ‘read access’. What if the writer misunderstood the brief? In this case, it would obviously be better for everyone if they could get back on track as soon as possible.

Be a believer in bad first drafts! Encourage the sharing of feedback, suggestions for improvement and new ideas from day one. This will lead to documents of higher quality, while at the same time improving efficiency.


Table 1: Benefits of a web-native database document collaboration system  
  Fact
Advantage
Benefit
 1  Web-based
  •  Work from multiple locations
  • Work with partners and sub-contractors
  • No local software installation
  • No need to distribute document – can give participants access
  • Always working on the latest version
 2  Data-based
  •  Several people can work simultaneously on the same instance of the document
  • Automatic updating of numbering, table of contents, list of figures, tables and attachments
  • Do not have to wait for document access
  • Eliminates the time spent on checking the numbering and creating lists for font matter
 3  Automatic layout
  •  Documents will always be identical to the corporate guidelines
  • Header and footer is consistent
  • Enhance corporate USPs
  • Increased focus on content
  • No time spent on formatting
  • Correct use of fonts, logos and colouring
  • Enhances branding
  • Documents always ready in PDF, HTML, XML or RTF (Word) format
  • Enhances quality of the document
 4  Complete transparency
  •  Can track the development of the document from day one
  • Control the process
  • No surprises towards the end
  • Possibility for management to give advice and guidance early on in the process
 5  Workflow
  •  Responsibility clearly defined
  • Individual deadlines
  • Several reviewers
  • Participants more likely to finish work on time
  • Order in the process
  • All reviewers can have their say before completion of the document
 6  Commenting tool
  •  All comments stored in one place
  • Can see colleagues' comments and give comments
  • Easy to have full overview
  • Do not lose the comments
  • All comments concluded
 7  Ability to copy across database
  •  Easy to resuse information
  • Automatic layout and formatting according to target template
  • Significant time saver
  • Simplifies process of using standard write-ups and the best of previous documents
 8  Blacklining
  •  Can easily track progress
  • Simplifies revision gate process
  • Can read changes quickly
  • Saves time
  • Increased focus on what is important

Reference

1. Egan D, Ghost in the Machine, BCBusiness Online, 5 August 2009, http://www.bcbusinessonline.ca/bcb/ top-stories/2009/08/05/ghostmachine# ixzz0pnFE0uvR


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Kris Sæther is Sales Director at Xait. He has a BSc in Graphics Media Studies from the University of Hertfordshire, UK. He has a background in publishing, print management and financial communication. Kris has experience in helping companies worldwide work smarter to enhance the quality of documents, such as proposals, governing documents and other business critical and time-sensitive documents.

Andreas Jordell is Business Development Manager at Xait. He has a BSc in Computer Science, an MSc in Quantitative Finance and an MBA in International Business. He has a background in risk management consulting and business development in the Norwegian petroleum industry, most notably the development of ArcticWeb – a data sharing geoportal adapted to the requirements of the offshore energy industry.

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