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Have you ever wanted to tear your hair out over revisions to a complex document or proposal?

We recently worked with a team responding to an RFP (request for proposal) from a large state agency. The RFP itself was nearly 100 pages long. The proposal responding to th

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

is RFP would be in excess of 150 pages. Its preparation effort required input from workgroup members scattered from San Diego to Charlotte.

Up to this point the company had done many long, detailed proposals. Their products were complex and involved technology compo

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

nents, civil works (concrete, drilling, boring), and network infrastructure, each of which had to be spelled out in detail.

The proposal development method was "blunt" (I'll say blunt rather than "crude.") In an era of instant messaging and conferencing systems, for

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

_this_ task draft copies were sent back and forth to team members via email or, when the proposals began to top 15 megabytes in size, via an ftp (file transfer protocol) transfer to and from a shared server.

What's wrong with that? Even with smaller proposals they

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

began to face confusion as the proposal developed. A phone conversation from two geographically separated team members might go something like this:

> HERE: "I just changed the executive summary and added the pricing section. I renamed the document 'proposal-1.2.doc

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

and emailed it to you. When you get it look over my changes and add your integration section and send it back to me."

> THERE: "Okay, but I had already renamed my working copy to version 1.2 last night."

> HERE: "Well then, open your copy, rename it to version 1.2

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

.1 and send it to me that way. Which sections did you change?"

The person responsible for ensuring each set of changes was copied and pasted into the right places had many different pieces to keep up with, and the process didn't always go well. Arguments about who h

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ad made the most recent change and which document it was in were common.

An online search of ways to control this kind of version confusion revealed some additional confusion of its own. One system recommended for proposal writers includes building a tracking databa

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

se to log information on sections and changes, which doesn't really change the process; it just makes one person really busy keeping up with changes.

With the approach of this large RFP, something had to change. The proposal required text, graphics, photos, drawings

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

, and spreadsheets -- all properly tabbed and organized.

This is where we introduce [Subversion][svn]. Subversion is a revision control system designed by and for programmers to keep close tabs on multiple contributors' changes to large numbers of source files invol

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ed in most programming projects. Subversion is "open source" (OSS) software: software whose code is freely available to all ensuring its verifiable quality, that allows no vendor lock-in, and that often has the upfront benefit of no cost to purchase.

Subversion allo

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ws a remote user to "check out" a working copy of a folder from a secure repository. A secure repository can be thought of as a password-protected data warehouse where files are stored and managed. It may reside on your local drive, on an internal network, or be stor

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ed at a remote Internet provider. Subversion communicates with the repository through SSH (secure shell) which means access can be tightly controlled and that the data transfer is encrypted for safety.

You check out a "working copy" from the secure repository onto y

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

our local drive. From that time on you can add, remove, and make changes to your working copy content. Each time you "commit" these changes back to the repository, everyone working on the project -- no matter where they are -- has access to them immediately.

The bea

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

uty of this system is that multiple users can modify their working copy documents then commit those changes. By clicking on your working copy you can "update" and integrate everyone's changes into your working copy.

Additionally, Subversion encourages use of log mes

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ages -- descriptive text you add as you "commit" each round of changes. This log text works well as succinct, searchable documentation of changes made in the content being committed.

As I said before, Subversion was designed for programmers to track changes to their

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

code; we had to find out if it would work with complicated Word and Excel documents.

It worked flawlessly -- team members added detailed graphs and charts, mechanical drawings, and site photos, then simply committed those changes back to the secure repository with

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

a few clicks.

Each team member would occasionally right click his working copy folder and "update" his working copy, which retrieves and merges everyone else's changes into it.

As a result the proposal came together much more smoothly. The final result was over 150

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

pages that had to be printed and written to CD, nine copies each. Because the final document was a seamless whole (due to the subversion process), the production went quickly. Prior to this method, the proposal might end up being made up from a number of documents

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

'shoehorned' together.

Subversion can work for almost any group that produces documents, with multiple inputs by workgroups that may be separate geographically. This could include proposals, contracts, statements of work (SOW), or even a collaboratively written book

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Online work is as diverse as on site work. Online work is demanding because the owner needs to work alone, be a self-starter, and be able to handle a lot of text material on a screen. The ephemerality of the web is another issue - many websites seem to disappear as soon as they spring up, and Silliman suggests the need for archiving online work is a problem that needs to be resolved. A key issue with online work is keeping it fresh, and not letting people forget about the space because out of sight, out of mind.

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