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Whether you are recording dictation, interviews, conferences, focus groups or meetings, it is important to know how to get the best quality recording, how to find a competent transcriptionist, and what sort of costs you are looking at.

The type of transcription depends on the type of recording equipment you have. You can record on to standard audiotape, micro or mini tapes, mini-disks and digital files, which the transcriptionist plays back on a

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

computer. If you don’t already have recording equipment, bear in mind that while a mini tape Dictaphone, for instance, might be much cheaper then a fully functional digital conference recorder with several external microphones, the quality of the cheaper instrument makes it suitable only for basic dictation.

Some mini and micro tape recorders are powerful enough to be placed on a table between an interviewer and interviewee and pick up both voi

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

Examples of combination products may in

ces, but we strongly recommend you carry out a test recording first to make sure. To record a focus group or conference you will need a good system of powerful microphones which will probably record into a video, digital audio or standard tape system. Digital systems are very variable and many are of good enough quality to record focus groups and conferences.

It is also worth bearing in mind that more and more transcribers no longer offer tape t

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

anscription, as digital is becoming so much more popular, and it is easier to work with and better quality.

On average it takes four hours to transcribe one hour of recording, but this varies considerably. It might be closer to three hours for one person speaking into a Dictaphone but could well be at least six to eight hours for a large focus-group.

This is because we speak much faster than even the fastest typist can type. Also, the transcrip

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

tionist doesn’t just type what he or she hears - it has to make sense. Although your transcriptionist should only type what’s being said (unless specifically requested to edit), it's not just a matter of the right words, but also the right punctuation and, of course, picking the correct homonym (e.g. there or their; two, to or too; pare, pear or pair; fair or fare; the list is almost endless).

You will also need to decide whether you want a ‘ver

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

Combination pro

atim’ transcription with every um, er etc. transcribed and all interruptions etc. noted. This is necessary for some work, such as police transcription, but is completely pointless in, for example, conference transcription, as the important factors in the latter are readability as well as accuracy.

The time taken to transcribe a recording can vary according to a number of factors. These include:

*Clarity of speech - Strong or varied accents slow

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

down the transcription.

*Clarity of recording - background hiss will make the speech more difficult to hear and therefore slow down the transcribing. Also, if a number of people are being recorded, the positioning and number of microphones can make an enormous difference to the quality of recording.

*Background noise - a recording in a pub or caf? is likely to have significant background noise and deciphering the speech from the background noi

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

e can be difficult.

*Number of people talking - everyone talks at a different rate and pitch, and with a different accent. Having to 'tune in' to a number of different people slows down the speed of transcription.

People also talk over each other and interrupt, and in order for the transcriptionist to transcribe two people talking over each other they will have to play back the section of recording several times to pick out the different voices

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

.

*Speed of speech - as already mentioned, some people speak faster than others. Clearly a fast speaker will take longer to transcribe, as they will fit more words in to an hour than a slower speaker.

*Whether speaker speaks in coherent sentences - few people actually do speak in the same way as we write. There are usually multiple 'ums and ers' and people often speak in partial sentences. This can require the transcriber re-listening to a sect

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

on several times to grasp the meaning and insert the relevant punctuation.

*Whether you are seeking an exact transcription or a transcription 'for meaning'. Our standard offering at Penguin Office Services is to transcribe word for word but to leave out 'ums and ers' and repeated meaningless phrases, such as 'you know', and 'know what I mean?' It is obviously quicker to leave out these parts, but we are happy to transcribe them if required. An e

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

xample of when an exact transcription might be required is academic research interviews studying language use.

So if you want to make sure you get a good quality recording, what can you do? Firstly, use the best quality recording equipment you can afford. This really is a question of getting what you pay for. A low-cost recorder may seem economical but the quality will be comparatively poor and a poor recording will take longer to transcribe. Pa

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

Following aspects would a

ying for more transcription time will probably work out more expensive than spending a few pounds extra on better recording equipment. Digital recording must be the way to go if you are starting from scratch. Minidisks make very good quality recordings but only a few transcriptionists can transcribe from them. At Penguin Office Services we can convert Sony Minidisk recording to computer-based audio and transcribe from that. If you are not going d

dd to the challenges in developing combination products:

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

wn the digital route then standard audio tapes make better quality recordings than mini tapes, though micro tapes are also good for interviews and one person dictations. If you are using tapes, by all means keep a back-up copy but do send your transcriptionist the originals, as back-ups may be reduced quality.

Secondly, record in a quiet environment such as a self-contained office. This will make an enormous difference to the quality of recordin

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

g. If you need to record in an open-plan office or public space then try to ensure your microphone is placed close to the speakers you are recording, but as far as possible from other workers in the office and their phones, or other people in a public space. Recording in pubs, restaurants and cafes, trains etc. will greatly reduce the quality of recording. If the speaker has a very quiet voice the recorder will not pick it up. Although you don't

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

ant to remind people that the recording equipment is there, you may have to ask them to speak up or place the equipment closer to them.

Thirdly, bear in mind that most built-in microphones are of poor quality with limited control over volume levels. They are designed to pick up close speech such as someone speaking directly into a Dictaphone. Using a good quality microphone for interviews and other multiple speaker recordings will greatly improv

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

e quality and reduce transcription time.

It is essential to ensure that the speaker is close enough to the microphone. If there are several speakers, for example in a seminar or conference, ensure that there are sufficient microphones around the room to pick up ALL the participants clearly. If seated around a table use something like a Conference mixer, which links several microphones to one central unit that will pick up a discussion more clear

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

Professional from academic institutions, pharmaceutical industries, health care indust

y than one central microphone.

If you are chairing a focus group you should ensure that all participants know that they must speak clearly and one at a time or their words will not be clearly recorded. There will be times when participants get exited and interrupt each other. When this happens it may be sensible to interrupt and ask them to repeat, one at a time, so that all the words will be clearly recorded.

There are also a couple of things

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

you really should avoid doing, and these usually apply to tapes, rather then digital. Some recorders can tape at slower speeds, extending the recording time and reducing the number of tapes used. However, there is a related loss in recording quality. We would recommend that you use only the fastest speed setting on your recording equipment. Also, some recorders have a voice-activation system so that you don't waste tape recording long pauses. How

.

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

ver there are two serious problems when using this. The first is that a soft-voiced person might not activate the recorder at all, so that whole sentences might not be recorded. The second is that every time somebody does speak and activate the recorder there is a slight time delay before recording starts, so the first word or two will probably not be recorded.

Finally, where you have speakers at a podium or multiple speakers in a large room, it

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

Companies that provide selfless information through particip

is advised that you seek professional help to ensure everything is clearly recorded. Most hotels and conference centers will have in-house experts, or a company specializing in audiovisual equipment should be able to help.

If you have decided to use digital recording, there are quite a number of things to bear in mind when choosing your recorder. Please see my separate article, ‘Digital File Types for Transcription’ for more information on this

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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