Tags |
|
|
Links |
|
|
Advice You - Ten Outsourcing Fears and Steps to Ward Them Off
Outsourcing your non-core operations to a service provider has ceased to become a prerogative. Almost everyone is doing it even the top Fortune 500 companies. Definitely, outsourcing has become another option for business viability and survival.
Apart from lowered cost and enhanced qual
Apart from lowered cost and enhanced qual
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
ity of work, outsourcing enables companies to tap the expertise of the outsourced service provider into its own operation, thus the outsourcing company stands to benefit more than just getting its non-core jobs done by an outsource provider. Yet, as beneficial as it seems, there are atte
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ding risks. Just like an ordinary business transaction, outsourcing, too has loopholes.
Here are ten (10) outsourcing risks identified and the steps to ward them off:
RISK #1: Outsource provider’s track record.
Taking a closer look at the outsource provider’s number of years in
Here are ten (10) outsourcing risks identified and the steps to ward them off:
RISK #1: Outsource provider’s track record.
Taking a closer look at the outsource provider’s number of years in
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 outsourcing industry, size of his company as to number of his employees when he started out compared to his present organizational structure, taking into account the ratio of employees’ turn-over, his financial background, etc… - all these are determinant factors of an outsource pro
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ider’s track record.
RISK #2: Competencies.
Is the outsource provider competent to deliver quality services? Is the outsource service provider ISO9000 compliant, or are there verifiable certifications from competent independent agencies like CMM, issued in its favor? What are th
RISK #2: Competencies.
Is the outsource provider competent to deliver quality services? Is the outsource service provider ISO9000 compliant, or are there verifiable certifications from competent independent agencies like CMM, issued in its favor? What are th
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e procedures the outsource service provider undertake to ensure that it delivers quality service?
Clients’ references are the best source of information concerning competencies of the outsource service provider. Their satisfaction guarantees yours, too.
RISK #3: Hidden costs.
Clients’ references are the best source of information concerning competencies of the outsource service provider. Their satisfaction guarantees yours, too.
RISK #3: Hidden costs.
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
he apparent reason why you outsource is cost. Undeniably, outsourcing cuts down cost, but be wary about hidden costs that can spring like panthers aiming for your throat!
Areas to watch include connectivity expense, infrastructure maintenance and development, transition cost, licensing
Areas to watch include connectivity expense, infrastructure maintenance and development, transition cost, licensing
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
and consultancy.
RISK #4: Meeting deadlines.
Are commitments attainable? Is your outsource service provider apt to the challenge of delivering to you the service you need within prescribed, and agreed upon, time frame?
RISK #5: Data safety.
Now, caution should be emphas
RISK #4: Meeting deadlines.
Are commitments attainable? Is your outsource service provider apt to the challenge of delivering to you the service you need within prescribed, and agreed upon, time frame?
RISK #5: Data safety.
Now, caution should be emphas
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
zed here. You will be sharing information about your business with your outsource service provider. Is non-disclosure agreement an issue? Get an affirmative response from your outsource provider that any information, data or work processes that concern your business should not be disclos
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
ed to a third party. A privacy statement should be included, and form part of your contract with him.
Your team at the outsource service provider’s company should undergo pre-hiring orientation which will inculcate their adherence to non-disclosure of vital information and privacy agree
Your team at the outsource service provider’s company should undergo pre-hiring orientation which will inculcate their adherence to non-disclosure of vital information and privacy agree
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ents.
Security settings such as firewalls, anti-spam ware, access controls and data encryption should be discussed and agreed upon as well.
RISK #6: Contingency Plans.
Find out about contingency plans. Does your outsource service provider have one in place?
Your outsource serv
Security settings such as firewalls, anti-spam ware, access controls and data encryption should be discussed and agreed upon as well.
RISK #6: Contingency Plans.
Find out about contingency plans. Does your outsource service provider have one in place?
Your outsource serv
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ce provider should have considered measures to undertake before any contingency strikes. Equally important are its recovery plans. How well does your outsource service provider expect to continue with its business should a disaster occur?
Businesses are beset with risks. When you outsou
Businesses are beset with risks. When you outsou
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
rce, you become involved with whatever risk your outsource service provider face up to. It is best to know that you will be dealing with a service provider that has foresight. This is a sign of maturity and responsibility.
RISK #7: Transparency.
Always invoke transparency betwee
RISK #7: Transparency.
Always invoke transparency betwee
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
you and your outsource service provider in all phases of your business undertaking. This will immobilize intrigue, dissension, and will affirm trust.
Is invoicing done on time? Are contracts feasible?
Eradicate minor flaws as they take root, by being transparent and trustworthy. This
Is invoicing done on time? Are contracts feasible?
Eradicate minor flaws as they take root, by being transparent and trustworthy. This
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
will be the ground upon which your business will flourish.
RISK #8: Adherence to labor laws, state laws and regulations.
Your outsource service provider should operate within the legal tenets of its own country. Its non-conformance of state laws, regulations, ordinances, etc… wi
RISK #8: Adherence to labor laws, state laws and regulations.
Your outsource service provider should operate within the legal tenets of its own country. Its non-conformance of state laws, regulations, ordinances, etc… wi
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
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
l affect you, if not legally, then on moral decency.
You as the outsource service provider’s client should ensure your moral ascendancy in environmental concerns, and employees’ welfare.
RISK #9: Employees’ Issues.
Cross-training of employees is necessary to avoid disputes and
You as the outsource service provider’s client should ensure your moral ascendancy in environmental concerns, and employees’ welfare.
RISK #9: Employees’ Issues.
Cross-training of employees is necessary to avoid disputes and
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
needless work stoppage. As most outsourcing is done to foreign countries, employees should receive orientation as to what they can expect from a foreign client, as well as the client understanding situational factors, such as time-zone difference, length of work hours, etc… from the poin
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
of view of employees.
RISK #10: Cultural Match.
Akin to risk No. 9 is finding a “match” or a “fit” between the outsource service provider and the client. Cultural factors can influence, positively or negatively, the outcome of the working relationship. For a suave interaction,
RISK #10: Cultural Match.
Akin to risk No. 9 is finding a “match” or a “fit” between the outsource service provider and the client. Cultural factors can influence, positively or negatively, the outcome of the working relationship. For a suave interaction,
.
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
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
the “fit” should be found.
A mismatch can cause problems ranging from pre-termination of the contract, faster turn-over of employees and a host of other concerns. Any of these reasons means loss for both parties.
Most common reasons why outsourcing goes sour are outsourcing services ge
A mismatch can cause problems ranging from pre-termination of the contract, faster turn-over of employees and a host of other concerns. Any of these reasons means loss for both parties.
Most common reasons why outsourcing goes sour are outsourcing services ge
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ting expensive or poor performance by the service provider.
The key is to choose wisely and carefully. Avoiding guesswork will eliminate unnecessary expense, wasted time and efforts. Selecting a service provider who possesses integrity, honesty and competence remains a sure-fire formula
The key is to choose wisely and carefully. Avoiding guesswork will eliminate unnecessary expense, wasted time and efforts. Selecting a service provider who possesses integrity, honesty and competence remains a sure-fire formula
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.adviceyou.org.ua/article/32840/adviceyou-Ten-Outsourcing-Fears-and-Steps-to-Ward-Them-Off.html">Ten Outsourcing Fears and Steps to Ward Them Off</a>
BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/32840/adviceyou-Ten-Outsourcing-Fears-and-Steps-to-Ward-Them-Off.html]Ten Outsourcing Fears and Steps to Ward Them Off[/url]
Related Articles:
6 Tips Every Entrepreneur Should Know for Living With Life Change While Running A Small Business
Handling Tough Questions from Tough Audiences
Bookmark it:
|