Useful Advices - Business

Document Collaboration has made leaps and bounds since the explosion of the technology revolution. In any business era, the need to collaborate remains a constant. What varies i

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

s the ability of technology to keep up with demands of the collaborators. Groupware has risen to the challenge, delivering solutions that streamline the editorial process - tra

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

Examples of combination products may in

cking documents, sorting, and even merging documents, essentially answering the who, what, when, where, and how of collaboration.

Even within the family of groupware solutions,

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

new technologies are available to take document collaboration to a higher level. Since all groupware technology is not created equal, it is important to search carefully. Milli

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

ons of indexed pages on your favorite search engine become the one groupware every business is looking for when searching through the newest technologies available in groupware.

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

Combination pro

Digital Thread technology, Version History, and Document Signature services form a new “triple threat” in document collaboration technology. It is a time-saver, an energy-save

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

r, and a money-saver.

In business efforts to preserve the bottom line, effective management and thorough record keeping are paramount.

Consider the following example:

Negotia

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

tions for a contract between company A and company B have been going on for months, with law firm C as the author and mediator of the contract. Three representatives from A and

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

B have been part of a drafting committee with a partner from C, making a committee of seven, each with various electronic records of by laws, budgets, minutes, and memos. The de

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

adline for the final draft of the contract falls due in a few weeks.

This could be a create-your-own-ending story, and you will see two alternative endings.

First ending: The

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

committee has a semi-organized pile of various drafts of files distributed over seven separate hard-drives, with numerous copies of the drafts sent via email to the other member

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

Following aspects would a

s of the committee. The report is almost ready to be merged; however, as the committee members survey the documents on their drives and emails accounts they realize they do not

dd to the challenges in developing combination products:

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

know who made certain changes, which drafts they are to merge, when each of the changes were made, where the drafts are stored, and how they are going to merge the changes all w

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

ithin the month remaining until the deadline.

Second ending: The committee has a semi-organized pile of various drafts of files distributed over seven separate hard-drives, wit

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

h copies of the drafts sent via email to the other members of the committee. The report is almost ready to be merged. Throughout the negotiating and drafting process, law firm C

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

has had Digital Thread technology inserting tracking data into the each document which the committee has worked on. Because all of the documents have been tracked, even though

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

Professional from academic institutions, pharmaceutical industries, health care indust

others on the committee may not have Digital Thread, the representative from law firm C can see the genealogy of every document and its who, what, when, and where with Version H

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

istory. Representative C has spotless documentation because every time she sees a Document Signature at the bottom of the first page of the document telling her which draft she

.

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

opened, when the latest changes were made, where it is stored, and who has taken action on it.

Representative C merges the documents without disrupting the order of the suggest

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

Companies that provide selfless information through particip

ed changes, finalizes the document, rechecks the final draft with both parties, and still has time before the contract is due.

This is of course a make-believe story, or is it?

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

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.usefuladvices.org.ua/article/4812/usefuladvices-Groupware-The-Triple-Threat-of-Document-Collaboration-Technology.html">Groupware: The Triple Threat of Document Collaboration Technology</a>

BB link (for phorums):
[url=http://www.usefuladvices.org.ua/article/4812/usefuladvices-Groupware-The-Triple-Threat-of-Document-Collaboration-Technology.html]Groupware: The Triple Threat of Document Collaboration Technology[/url]

There is one powerful strategy all event and meeting planners use to reach the level of success they really dream about. It has nothing to do with event themes or locations, or your budget. It has nothing to do with your training in the industry. What I am talking about is much more powerful, and has the potential of positioning you as #1 in your industry and to generate business you never thought possible.

Business pain is one of the most talked about items at any sales meeting. Managers constantly talk about the pain without realizing there are symptoms that can actually be treated.

It is the inherent desire and need of every business to grow both vertically and horizontally. Organic growth, that is development from within, is often slow and sometimes difficult. That is why there is an increasing trend towards mergers and acquisitions. It could be called an instant expansion.

Tags

Links

Useful Advices - Groupware: The Triple Threat of Document Collaboration Technology

Related Articles: