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The slight decrease in the IT dynamics at the beginning of 2000s being over, the new drivers has fueled further development of the IT branch throughout 2006 – 2007.

One of the tendencies of the global

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

impact has to deal with growing business value of the Internet as well as associated boom in e-commerce. The IT-rich enterprises have won substantial market advantage over the competito

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

Examples of combination products may in

rs that have not placed IT as the key element of their business strategy. According to Gartner, the investments in the new information technologies would double within 2006 – 2010 period

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

The burning IT issues of the two previous years have included digital convergence, mobility and Service-oriented architecture. Other point of focal interest turns out to be the alignment of IT and business proce

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

sses within the enterprise in general and in sourcing models in particular.

The analysts from Experton Group have come up with the statement that in the next few years outsourcing "would be the driving force behi

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

Combination pro

d IT market dynamics". Despite the global slow down in outsourcing dynamics – for the most part in America, the number and quality of outsourcing contracts concluded in Europe has risen during the first

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

quarter of 2007 (Morrison & Foerster's Global Sourcing Group). The year 2007, alike the previous one, has demonstrated the increase in the IT staff, despite the forecasts for decrease due to the outsourcin

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

g of IT activities. Hence, it proves out that outsourcing strengthens the market position of outsourcing buyers, expanding their technological scope and consequently creates new workplaces.

During the pa

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

t few years we have seen the shift occurring in decisive factors for outsourcing: in addition to traditional reduction of development costs, outsourcing buyers become more and more interested in access to

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

the pool of talents (due to the internal shortages of highly-qualified IT graduates) and industry-specific know-how. Another visible trend of 2007 is multisourcing, accompanied by growing process-orientation. The

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

time of "mega-deals" is left behind, while overwhelming reduction of the contract’s scope becoming a nowadays reality. "Gartner’s Key Predictions for 2007" include the forecast that through 2009,

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

Following aspects would a

market share for the top 10 IT outsourcers will decline to 40.0 percent (from 43.5 percent now), equalling a revenue shift of $5.4 billion. The above mentioned trend consequently leads to the growing number of

dd to the challenges in developing combination products:

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

SMEs on the IT arena and therefore the increase of the impact on the outsourcing landscape.

Precise attention should also be devoted to the Top Trends 2007, outlined by CIO Insight: particularly, Managemen

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

section of the forecast features predictions that outsourcing will change IT management and that offshoring will shift from India. Concerning the later tendency, notwithstanding pure neashoring, it is wo

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

rth to note that Indian outsourcing providers are increasingly seeking possibilities for mergers with Eastern European software developers. Inevitably, outsourcing "moves closer to home", with Indian and

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

hinese outsourcing proposals becoming less appealing to European vendors.

Over the years, data privacy as well as data security has become fundamental prerequisites for successful outsourcing cooperation. Therefo

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

Professional from academic institutions, pharmaceutical industries, health care indust

re, intellectual property issues together with effective practices on risk mitigation will stay top of the agenda for the years to come. Also, outsourcing service providers are expected to be capable of d

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

riving innovation and delivering industry specific know how. Another trend of interest, highlighted by Morrison & Foerster’s Global Sourcing Group, introduces transformational application outsourcing, whi

.

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

h foresees restructuring of the code in a more modern architecture, therefore making it deployable in SOA.

To sum up with, the coming years will see tighter alignment between outsourcing providers and software de

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

Companies that provide selfless information through particip

velopment vendors, resulting in more effective business cooperation models. Also, increasing competition will fuel more innovative approach to outsourcing, with process orientation becoming the core of 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

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