Advice You - Business

Business processes generate a mountain of data. The challenge facing business owners and managers is to use that data to make intelligent decisions. So where do you start? Is every data item nec

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

essary? How much is all this going to cost?

The place to begin whittling down the data pile is to identify the company’s critical goals and the activities that have the greatest impact on achie

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

Examples of combination products may in

ving them. Critical goal are those having the biggest effect on the bottom line; achieve them and you’re in fat city, miss and you find yourself before the stakeholders begging for your job. On

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

e you set the goals and determine the data to use as indicators your 90% home. The only thing that remains is selecting which option to use to keep it all organized.

The high cost option is an

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

out of the box, customizable dashboard, an automated system that interfaces directly with you your business process. One that collects and collates data in near real time so it can be presented

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

Combination pro

to you in the comfort of your own office on your monitor, accurate and timely. There are quite a few good ones out there and it’s the way to go if you have the budget to buy the system and you h

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

ve the processes for the system to tie into. Chances are there are more business that can’t or don’t than there are those that can and do.

We all want to make the best decisions whether we’re a

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

one person operation or a public giant. We need something simpler and less expensive. The answer in this case is your favorite spreadsheet program, the one that came bundled with all your other

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

software. That spreadsheet and your telephone provide you with all the tools you really need to put together a dashboard. Without getting fancy they can be set up quickly, data can be entered e

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

sily and your information can be presented visually.

Now for the benefits.

1. Dashboards improve communication. It can be a complicated process to keep communication channels f

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

rom becoming crossed and confused. In many instances, a dashboard can reduce or completely eliminate the need for confusing memo, meetings and conversation. Want to see how sales are doing in ano

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

Following aspects would a

ther branch or territory? Want to know what the award of a big contract is going to do to the bottom line? Get straight, simple answers at the click of a mouse.

Furthermore, you can access your

dd to the challenges in developing combination products:

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

data from home or on the road using a Blackberry, a PDA, or other piece of mobile technology. Dashboards improve communication by making data easier to comprehend and more up-to-date, it also ma

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

kes it more accessible.

2. Dashboards save time. Decision makers need the flexibility to recognize and act on trends. A dashboards’ real time, or near real tim

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

e access permit this by saving historical data and producing charts, graphs and tables on the fly. No more spending days in the file room sift through pages of confusing or complicated numbers to

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

find the needed figures, collating them and then sitting down with a calculator to create actionable information. If you’re using one of the out of the box alternatives the information is immedi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ately available. If you’re relying on an automated spreadsheet, the information is never any older than the last time you entered the data.

3. Dashboards eliminate guesswork. T

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

he data, either acquired or entered, is accurate and can be presented in a way that is clear and precise. Your dashboard also allows you to calculate alternatives based on “what ifs” and conditi

.

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

nal assumptions.

While a dashboard can present data it can’t provide answers but it can speed up, and simplify the decision-making process ensuring that the decision maker acts with the best ava

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

Companies that provide selfless information through particip

ilable information. Not a member of the senior management team? No problem. Any employee regularly supporting achievement of their own or their organizational goals is a candidate for a dashboard

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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Your bookkeeping or accounting system should protect your business from fraud, provide useful information to help you manage your business and make your business more efficient. It should assist you with keeping track of quotes, stock and outstanding debts.

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