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Advice You - Minimising Risk in Outsourced Projects
Introduction
Outsourcing is the process of contracting a third party to do work on the behalf of the client that they have neither the skills or resources to perform in-house. It is usually more cost
Outsourcing is the process of contracting a third party to do work on the behalf of the client that they have neither the skills or resources to perform in-house. It is usually more cost
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
effective to contract out work than to hire someone in to complete the task in question.
The other benefits include being able to perform several parts of the project in parallel, thus reducing time
The other benefits include being able to perform several parts of the project in parallel, thus reducing time
; 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
to market. Taking advantage also of geographic differences in the cost of implementation in IT projects can also help to bring costs down; outsourcing development to countries such as India and those
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
in Eastern Europe, for example, is a common practice.
The benefits do, however, come with some pitfalls. Chiefly among them us the lack of control that is experienced when outsourcing, and care must
The benefits do, however, come with some pitfalls. Chiefly among them us the lack of control that is experienced when outsourcing, and care must
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
be taken to be ensure that the gains in cost and time are not lost in over-managing the outsourcing process.
Involving third parties as brokers in these situations can alleviate this risk. In essence
Involving third parties as brokers in these situations can alleviate this risk. In essence
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
the project management is outsourced to a middle tier service provider capable of arshalling the best capabilities of the open market.
The Risk of Total Outsourcing
The riskiest path to take is th
The Risk of Total Outsourcing
The riskiest path to take is th
ucts have become life saving products for the pharmaceutical companies who doesnt have many innovative molecules in their product pipeline and have been inc
at of total outsourcing; placing part of the project entirely in the hands of a third party. This may be because the task is so labour intensive or technical that the client is unable to service any p
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
art of the task themselves.
Thus, trust is placed in the experts to produce something which would not otherwise be possible. With that trust comes the additional burden of risk management. The danger
Thus, trust is placed in the experts to produce something which would not otherwise be possible. With that trust comes the additional burden of risk management. The danger
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
is always there that the lack of control will lead to project overruns, and hence higher costs than anticipated.
Since the task is outside the expertise of the client, they can often neither control
Since the task is outside the expertise of the client, they can often neither control
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
nor verify that the lack of control is a natural phenomenon. This is compounded by the fact that the contractor could effectively blind the client by the science of the service that they are offering.
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
In IT projects, this is one of the key risks involved in outsourcing.
Competence Outsourcing
To combat the risks associated with total outsourcing, outsourced projects should stay within the availa
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
ble competence; something which sounds obvious, but really is not. Given that the reason for outsourcing is that the task can not be achieved in-house, the logical conclusion is that it must lie outsi
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
de available competence.
The paradox is easily solved : hire staff with equivalent, or related competences. This avoids all the issues associated with total outsourcing, but can prove to be as expens
The paradox is easily solved : hire staff with equivalent, or related competences. This avoids all the issues associated with total outsourcing, but can prove to be as expens
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
ve as having the task performed in-house.
The alternative is find a project management team with both technical and non-technical skills. If the task to be outsourced is a single project within a por
The alternative is find a project management team with both technical and non-technical skills. If the task to be outsourced is a single project within a por
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
tfolio of business activity, then it follows that hiring permanent staff to perform this function is probably going to be out of the budgetary scope of the company.
'CoSourcing'
This is where CoSour
'CoSourcing'
This is where CoSour
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
ing comes into play. In essence, it is two tier outsourcing, using a third party as a buffer between the highly technical project staff and the (usually) less technically competent client.
The key is
The key is
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
in minimising the number of project firsts. The most risk is when the client is outsourcing for the first time, in a new project, with technology they have never approached before. CoSourcing reduces
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
three project firsts to one.
CoSource provides a single interface to many competencies, enabling an approach that can fulfil the entire project lifecycle. Even if some aspects were not designed to b
CoSource provides a single interface to many competencies, enabling an approach that can fulfil the entire project lifecycle. Even if some aspects were not designed to b
.
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
outsourced, clients can often find that the CoSource model allows them to find economies of scale within the projects as they unfold.
It is a win-win-win situation; the client enjoys superior servic
It is a win-win-win situation; the client enjoys superior servic
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
e while making a significant cost saving, the contractor saves time in communicating with a technically minded project management team, and CoSource can continue to build on a solid base of experience
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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