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Before Gertrude Ederle began her historic swim off of Cape Griz-Nez, France, she underwent extensive training for endurance and technique—even though she was already an accomplished record-breaking swimmer

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

with Olympic medals to her name. Outsourcing IT may not garner the same attention as being the first woman to swim the English Channel, but it is no less important to gather as much experience and knowl

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

Examples of combination products may in

edge as possible on a small scale before diving in for the big swim.

The trend toward IT outsourcing is increasing dramatically. According to a report by Foote Partners, as much as 45% of North American I

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

T work will be outsourced by 2005. And there are good reasons behind this trend. Bruce Caldwell, principal Gartner analyst believes companies can generate 20-30% savings through outsourcing. This substan

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

tial savings potential isn't easily overlooked, yet it isn't the number one reason companies are choosing to outsource right now. In a recent survey by The Outsourcing Institute, the primary reason behind

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

Combination pro

outsourcing is to improve company focus. Other motives include freeing up internal resources, accessing top-notch capabilities, and accelerating time to market. The survey also indicated that 55% of firm

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

s who outsource do so within IT—more than any other area.

As more companies begin outsourcing some or all of their IT function, it becomes difficult to ignore the competitive pressure. With competitors ac

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

hieving their IT needs at 20-30% less cost, and getting ahead in the market because of increased focus within the company, those who ignore the outsourcing trend could potentially lose ground very quickl

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

y.

At the same time, outsourcing horror stories abound. According to Gartner research firm, half of the current outsourcing projects will not meet the company's expectations and will be considered failure

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

s. While the vast majority of these failures are only minor disappointments where the company decides to outsource to another vendor, certainly a few are major catastrophes. An anonymous case study in IT

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

Metrics Strategies discusses a CIO who chose to outsource to beat competitors to market. The outsourcer had promised to meet a deadline his staff had said was impossible. When the outsourcer failed, the C

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

Following aspects would a

IO couldn't rebuild his team fast enough to finish the job. In the end, the product never got to market at all.

So how do you secure all the benefits of this outsourcing wave without getting dragged into

dd to the challenges in developing combination products:

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

the undertow? The key is strategic, selective outsourcing. According to Corey Ferengul, VP of the IT research firm META Group, an increasing number of companies are choosing to outsource non-core IT tasks.

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

Common responsibilities going to third-party providers include Web hosting, call centers, data storage, and database administration.

"There's a learning curve and a life cycle to outsourcing," said Caldw

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

ell, "and it can be expensive finding the right vendor, as well as going through the transitions of taking your operations to that vendor." Stable, yet customizable IT functions provide an excellent trai

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

ning ground for outsourcing. Any function with known benchmarks for performance and results, as well as available, reliable outsourcing partners is a good place to start.

Ultimately you may want to outsou

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

Professional from academic institutions, pharmaceutical industries, health care indust

rce your entire IT department, but first you need to get a handle on managing an outsourced process. Some companies may discover they don't need to incur the risks and organizational chaos of switching to

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

total IT outsourcing. By nimbly carving out and outsourcing small pieces of the IT function that deliver the most cost and quality benefit, companies may find they are already receiving maximum savings a

.

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

t minimal risk. However, they will have done some carefully planned and executed experimentation before making that decision.

Gertrude Ederle once said of the sea "I never feel alone when I'm out there." Th

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

Companies that provide selfless information through particip

e channel became her ally as she swam her way to England in record time. By starting on a small, strategic scale, you'll turn IT outsourcing into your ally rather than a cold, tumultuous, foreboding sea.

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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The food services industry has developed a lot during these past years, mainly because it is essential for restaurants to work proficiently by stocking restaurant equipment and supplies to meet every possible customer demand.

It can be tough enough to generate profits, reinvest in the company and make payroll (even if you only have to pay yourself). Marketing often gets left off the list when a small company runs out of time, money or energy. But marketing does not have to be expensive. Here are five things you can start doing tomorrow to market your business that don’t cost a lot of money—and can pay valuable returns.

Once a rough draft of the questionnaire has been designed, the data acquisition team must take a step back and critically evaluate it. This phase may seem redundant, given all the careful thought that went into each question. At this point, the following items should be considered: (1) Is the questioning necessary? (2) Is the survey too long? (3) Will the questions provide answers to the survey objectives?

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