A contract research organization offering bioanalytical services will usually be an expert in the following areas
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Sectors spanning the pharmaceuticals and the biotechs require competent people who can offer
bioanalytical research services for varied purposes. Be it for small sample programs or proper hardcore
clinical sample analysis, the need for a good bioanalytical team will always be felt. Luckily, there are
several companies and organizations that offer the necessary technological support and expertise to
help clients with their clinical research.
A contract research organization offering bioanalytical services will usually be an expert in the following
Some of the services offered include:
Assay development - They collaborate with your internal teams to help you make important decisions.
The idea is to develop unique but effective solutions optimized to your needs to assist you through the
entire phase from discovery to pre-clinical and clinical development, manufacturing and post-marketing
Assay validation - This step is as important as assay development as it evaluates the accuracy and
ruggedness of an assay under diverse conditions. The rationale is to ensure that performance is in line
with the quality and compliance requirements at all costs.
Sample analysis - Be it in the preclinical phase or the clinical one, it becomes imperative to get reliable
results. The analysis should be reliable irrespective of the phase or the nature of study. CROs take great
care to live up to the expectations of their clients and hire people who take their careers and the nature
of this job very seriously.
Post-marketing surveillance - A good CRO will never leave you once the product is launched. It
understands the important of good support and the fact that their role does not end with the release of
the product. It offers post-market surveillance services too to gather data from broader market
demographics so as to ensure that everything is as per the quality and international regulatory norms
that were agreed upon.
Since companies lack the required expertise to conduct large molecule bioanalysis in-house, they hire
the services of reputed contract research organizations. Despite having the necessary capabilities, some
CROs may let you down. Lack of communication, failing to adhere to timelines, etc. can be important
reasons why you may not get the service you had hoped for. There are other complexities too that can
sour a good partnership. It is therefore important to choose a good CRO for bioanalytical services.
There are a few questions you may want to ask before choosing a lab or CRO for bioanalytical services.
Are they transparent about what testings are done in-house and which ones are outsourced? Are the
outside labs audited and is there a way to keep a tab on the quality and accuracy provided by the
outside lab? Are due precautionary measures taken to ensure quality and compliance? What are the
measures taken by the lab just in case results or study don't go as expected or an error leads to
conflicting test results? These are all important questions that you should ask before choosing the best
bioanalytical lab or services for your research.