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Many people are confused as to why transcription (audio typing) apparently costs more than copy typing, as both are typing services. This article aims to explain the differences

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

between the two services and what makes up the costs for a transcription service.

Firstly let’s take copy typing. This normally refers to the typing of written ‘copy’ – this m

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

Examples of combination products may in

ybe a previously typed document (perhaps typed on a typewriter and needing to be input into a Word Processor) or a hand-written document. The cost will vary depending on the eas

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

of readability but with basic copy typing there is no editing or interpretation required; the typist simply types what is written in front of them. The cost of the typing servi

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

es will vary according to how difficult the writing is to decipher – it will be relatively cheaper if the original document is very clear handwriting or type-written.

Transcrip

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

Combination pro

ion, on the other hand, has no copy for the typist to look at, only an audio recording, which may be an audio tape, video, DVD or audio digital recording. This brings with it a

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

umber of issues that copy typing does not have: is the speech clear; is the content comprehensible (e.g. highly technical content might be full of words the transcriptionist is

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

not familiar with); is the recording quality good (e.g. is there any background hiss on the tape or background noise from the surroundings the tape was recorded in); do you need

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

verbatim transcription (word for word with all ‘ums and ers’, speech patterns and fillers such as ‘you know’, ‘know what I mean’ or ‘kind of’ repeated often through the recordin

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

; do you want the transcript edited to improve the grammar and sentence structure?

Clearly transcription is much more involved than copy typing. Another thing to bear in mind i

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

that an hour of recording is not equivalent to an hour of transcription time. Even an experienced transcriptionist will be able to average four times as long for a good, clear

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

Following aspects would a

ne-to-one interview – so an hour of recording will take an average of four hours to transcribe. ( Industry standards obtained from the Industry Production Standards Guide (I998

dd to the challenges in developing combination products:

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

, published by OBC, Columbus, OH, USA) A group, or a poorly recorded transcript, will take commensurately longer. Thus when you receive a quote per hour of recording it may seem

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

like a lot of money, but remember this is NOT your transcriptionist’s hourly rate but rather a quote for a minimum of four hours of her/his time.

Transcriptionists also have to

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

make sense of what’s being said, punctuate the speech correctly and use the right homophones (words like there/their/they’re that sound the same but are spelt differently.)

Ma

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

y transcriptionists specialise in a particular area so that they are familiar with the technicalities e.g. medical transcription, legal transcription. Others are more generalist

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

Professional from academic institutions, pharmaceutical industries, health care indust

and work on less technical transcripts such as research interviews and market research focus groups, video or telephone conferences, seminars and conferences. These may all, of

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

ourse, contain technical data and if they do it’s helpful to provide your transcriptionist with a list of keywords or, at very least, some background information about your work

.

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

Otherwise Google is a wonderful tool if used properly to research the topic but that will add to the total time taken to produce your transcript, and therefore the cost.

Hopef

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

Companies that provide selfless information through particip

lly it is now clear that transcription requires more skill than ‘straightforward’ copy typing with no editing or formatting involved, and therefore commands a higher hourly rate

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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