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In today’s regulatory environment, timely, accurate and comprehensive information is more critical than ever. While traditional business intelligence (BI) solutions have dominated the corporate environment based on their ability

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

to quickly query, access and then report on information, they often lack the processes and metrics needed to measure and manage business performance. As a result, business performance management (BPM) solutions are gaining moment

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

Examples of combination products may in

m as a more complete way to address the need for financial transparency and provide users with a means to act on information.

“Companies are starting to realize that traditional business intelligence is not enough to improve bus

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

iness performance,” said Crispin Read, Chief Marketing Officer at Cartesis, the world’s leading specialist in finance and business performance management software. “BPM solutions are filling this gap, allowing companies to achiev

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

faster, more flexible planning cycles and to gain deeper financial insight.”

BPM: A More Integrated Approach to BI

Business Intelligence solutions unlock critical management information and attempt to put that informati

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

Combination pro

n in front of decision makers who need it to run the business. However, one of the challenges with BI tools has been that the data that they do unlock isn’t always consistent across the enterprise. For example, BI tools can’t add

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

up revenue numbers in different currencies because they lack the financial intelligence to translate from one currency to the other.

Another area where business intelligence solutions have fallen short is in addressing the requ

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

rement for financial transparency, one reason some traditional BI vendors have acquired BPM vendors for financial and performance management capabilities. The need for such transparency is greatest within finance departments wher

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

specific challenges demand just one set of numbers and ideally one set of applications. Whereas a business user of a BI query tool is generally satisfied with the content he gets and how this helps him look into defining next we

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

ek’s stock ordering, the group controller or CFO needs the most accurate, real-time information for mission-critical functions such as budgeting, planning, compliance with financial reporting regulations, and performance improvem

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

nt.

BI infrastructures have also become increasingly complex and costly, with large corporations managing dozens of silos encompassing OLAP databases, data integration tools, reporting tools and query and reporting analysis tool

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

Following aspects would a

.

Evolving perfectly to address these BI challenges is BPM with its more integrated, holistic approach.

“Performance management is sort of changing the mindset of BI and moving it away from the spot approach where five or six r

dd to the challenges in developing combination products:

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

eporting tools are involved,” said John Van Decker, Senior Vice President and Principal Research Fellow at the Robert Frances Group, an IT research and advisory firm based in Westport, CT.

Accuracy and Control

Beyond tra

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

sparency, BPM systems, such as the Cartesis 10 business performance management suite, ensure the consistency and accuracy of information that finance departments need to meet the requirements of external stakeholders and legal/re

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

ulatory bodies. Financial information can’t be used if it isn’t 100 percent accurate, and there is tremendous cost if it is inaccurate, including the potential for criminal charges against the CFO and other employees. And with so

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

much riding on the accuracy of a company’s numbers, finance departments need greater control over the budgeting and reporting processes — and the ability to look deeper into the numbers.

“Companies have to report accurate numbe

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

Professional from academic institutions, pharmaceutical industries, health care indust

s; if they don’t then they are in breach of a number of laws, and penalties will come down on the companies and the people who work for them,” Cartesis’ Read said. And accuracy is not only mission-critical for financial consolida

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

ion and statutory reporting applications but for planning, budgeting and forecasting, he said. “If you don’t know at the end of the month if you are over budget or under budget, then you are flying blind and you’ll crash the comp

.

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

any.”

Once a corporation is certain it has accurate information, getting that information to key decision makers quickly is vital. Cartesis 10 employs a single data model that ensures one source of accurate, consistent data betw

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

Companies that provide selfless information through particip

en applications, as well as between the people and business processes involved. The suite also provides auditing controls to allow the finance department to easily review and verify every accounting step from source to disclosure

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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