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Main Subject - Electronic Document Discovery
Documents are rarely in the physical form these days. Most documents are being created in the elec
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
tronic format, and even physical documents are being converted into electronic formats. Several de
; 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
vices, such as CD/DVD ROMs, floppy disks, hard drives and tapes, are being commonly used to store
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
documents. Document transfer is also in the electronic form through e-mails or the Internet and in
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
tranets.
When documents are created electronically, they are stored in temporary files. Even when
When documents are created electronically, they are stored in temporary files. Even when
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
they are deleted or updated, some remnants still remain on the hard disk, which can be recovered
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
using special tools. Thus, data that is lost or overwritten can, in fact, be retrieved. This is an
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
important aspect of electronic document discovery, which is being increasingly used in civil and c
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
riminal litigations to get useful evidence. Electronic document discovery is a very difficult task
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
due to the sheer volume of data present in the electronic form. Collecting, sorting, categorizing
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
and storing this data is an arduous task.
Computer forensic experts carry out electronic documen
Computer forensic experts carry out electronic documen
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
t discovery. These people deal with the preservation, identification, extraction and documentation
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
of computer evidence. They use software tools for the retrieval of data from any kind of an elect
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
ronic source. These tools are highly advanced and can categorize, search and sort for data in thei
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
native format. Reports can be generated within minutes, and documents can be redacted. Electronic
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
document discovery and management has become indispensable today. The electronic document discove
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
ry market was worth $1.3 billion in 2004.
Some of the electronic discovery tools are: Concordance
Some of the electronic discovery tools are: Concordance
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
(Dataflight Software Inc.), Summation (Summation Legal Technologies Inc.), CaseMap (Bowne Decisio
.
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
nQuest (CaseSoft)), Access (Microsoft Corp.), Attenex (Attenex Corp.), Encase (Guidance Software I
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
nc.), iConect (iConect Development), Introspect (ZANTAZ Inc.) and LiveNote (LiveNote Technologies)
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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