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A contract research organization offering bioanalytical services will usually be an expert in the following areas

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all about bioanalytical services

All about Bioanalytical Services

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

areas:

Cell-based assays

Biomarkers

Immunogenicity

Pharmacokinetics

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

surveillance.

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

conflicting test results? These are all important questions that you should ask before choosing the best

bioanalytical lab or services for your research.