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Questions about the CRO/Clinical Trials Indsutry

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Questions about the CRO/Clinical Trials Indsutry

Postby G.R. Kazan » Sun Nov 01, 2015 3:28 pm

I just started an entry level position as a Project Assistant in the CRO industry and I just had a few questions about it. I currently have a BS in public health/behavioral sciences.

Is the CRO industry a healthy industry to get into for a career?
Are there ample opportunities for growth and promotion in this field?

Or if anyone has tips about the subject just post it, anything would be helpful. Thanks.
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Re: Questions about the CRO/Clinical Trials Indsutry

Postby Dave Jensen » Sun Nov 01, 2015 5:54 pm

Hello, and welcome to the Forum.

The CRO industry is quite divided, so it's tough to make generalizations. For some, CRO stands for Clinical Research Organization and companies that do clinical trials on behalf of drug or biotech companies are all over the place, large and small. It's a big section of business, so it is really hard to say unless you talk about a specific sector of the CRO market, like "cancer therapeutics" and so on. But in general, that sector appears pretty healthy to me. We have others here like DX who may have more on this.

But in a broader definition, CRO stands for "Contract Research Organization," and this can mean any kind of third party service providers, companies which do a "piece" of the R&D for other firms who are outsourcing that effort. Both large and small companies do this outsourcing, it's not relegated to companies of a certain size. Small companies don't have the resources, so they'll hire analytical service providers with access to Mass Spec, for example. But large companies don't have all these capabilities either, or they do but they are overbooked in their core labs, so they outsource as well. Services can range from one tiny niche, perhaps a certain assay that the company runs which they are expert in, all the way to taking on a broad range of development -- for example, taking the "scale up" process from the company and figuring out what process is required for the company to build a manufacturing line around.

Another permutation of the CRO concept is the CMO -- the Contract Manufacturing Organization, and this might be a company that takes the hand off from the process development people I mentioned above, and then actually does the manufacturing of the drug in a GMP-certified and FDA recognized manufacturing facility. These are growing also, especially now that there are so many "bio-similar" drugs coming to market soon. This is rather a hot field at the moment.

I hope that this answers your question. As a BS with a public health background, I'm sure there will be opportunities in the operations and business side of these employers for you, and that you could enjoy a fine career, but it won't likely be in R&D.

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Re: Questions about the CRO/Clinical Trials Indsutry

Postby G.R. Kazan » Sun Nov 01, 2015 6:32 pm

Thank you so much for the information Dave. I'm specifically talking about the Elecrronic Data Capture (EDC) sector. Is there room for growth in a position like that? Tasks including things like data and file analysis and pushing important information to various players in the clinical trial phase.
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Re: Questions about the CRO/Clinical Trials Indsutry

Postby D.X. » Mon Nov 02, 2015 4:15 am

Hi G.R. Kazan,
Dave sums it up well and gives good direction on opportunities with someone with your background.

Regarding Electronic Data Capture, that can involve many many different aspects – from a CRO and Clinical Trial perspective one area of continued need is rapid, efficient and accurate patient level data-capture to include electronic data entry options for Case Report Forms (CRFs) as imputed by the site study coordinator(s) and managed by your CRO data management teams. There is also need to capture patient data beyond the study visit, so here lot of technology platforms are being established – cellular/mobile devices etc. all feeding into a centralized reporting system. Key data captured here would be patient adherence to study medication protocol, or certain Patient Reported Outcomes that need more frequent assessment beyond the study visit or even certain biometric parameters.

A lot of need for ensuring data is accurate, valid and analyzable - perhaps your background in public health can be leveraged here. Obviously in context of a Clinical Trial there is a high organizational level for Project Management here – a lot of things need to be coordinated to ensure a clean data-flow before, after, and during a study – a lot of coordination with many stakeholders etc.
There is growth or perhaps complexity that needs to be managed here – as clinical trials are capturing more data than ever, resulting in more information that needs proper capture and assessment – and accuracy is key.

Another area may leverages EDC fundamentals, so casting a bigger net – beyond clinical trials but where CROs are highly involved are epidimeologic and real-world data capture registries. A lot of focus on linking of Electronic Medical Record (EMRs) data-bases to assess outcomes linked to therapeutic interventions, or assess mortality/morbidity risks, etc. etc. So some big-data analytics coming into the equation.

A lot of growth here as patient data/outcomes capture becomes more and more electronic and a lot of focus on linking EMRs – there are a lot of health-policy implications here. In these cases, pharma companies are working hand in hand with government agencies and non-profits to understand in granularity disease burden, linkages and opportunities to assess which interventions are having both health and economic impact – obviously building to Health-Technology Assessment opportunities – underlying the growth in this area. A bit out of scope, but still requiring the same skill sets. But an area where CROs are playing along with thier Pharma Clients.

Good luck.

DX
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Re: Questions about the CRO/Clinical Trials Indsutry

Postby G.R. Kazan » Wed Nov 04, 2015 12:36 pm

Thank you for the info DX. To be specific, my major combined behavioral health and public health. My current entry level position is very basic, requiring me to complete tasks such as file review for trial documents, liasing with a site monitor, and coordinating conference calls. My question is, do you think there is room to move and grow to other positions in this field/industry with only a Bachelor's degree? and no Master's or PhD? I just don't want to hit a glass ceiling with the position I'm currently at.
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Re: Questions about the CRO/Clinical Trials Indsutry

Postby D.X. » Thu Nov 05, 2015 5:01 am

GR Kazan,

Unfortunately I can't comment here and refer you to Dave's post. If you do move into more scientific functions where data interpreation and dessemination is a part of the Job, then I propose a higher-level scientific degree would be advantagous for securing growth.

But here i recommend you do some informational interviewing with others in your area.

DX
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