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5 Drug Development Dilemmas to Avoid

Involved Contributor II
Involved Contributor II
shutterstock_144640304Bioanalytical labs are integral to clinical and pre-clinical drug development. From assay validation, analysis and sample tracking to reporting of results, the requirements are demanding. Couple this with the pressure to identify non-viable compounds as quickly as possible, and it is clear why bioanalytical labs can ill afford operational inefficiency. In order to be more efficient and utilize resources more effectively, avoid these 5 dilemmas:

1. Lost or untraceable data

Measurement traceability is hard. But if it’s taking place in the background, labs can dramatically reduce the time, expense and aggravation associated with defensibility. Managing data through software enables everything required for traceability to be continuously and purposefully organized for rapid retrieval, allowing analysts’ time to focus on identifying breakthrough compounds.

2. Failing to see analytical trends

Retrospective analysis is far less effective than predicting and preventing errors. Errors that mask QA/QC problems, for example, can mushroom into larger, systemic quality issues or create productivity gaps that eventually require costly instrument reconfiguration.

Statistical quality control (SQC) must be intrinsic in the lab’s everyday technology. A LIMS designed for clinical and pre-clinical drug development should have this capability built in to be able to detect non-conformance trending before it reaches pre-defined thresholds.

3. Sample mismanagement

Analysts need to be able to document sample information which is unique to bioanalytical labs. LIMS not fit for this purpose will likely require months of customization, if not more.

Sample management and transportation procedures are critical to GLP compliance, but can be hard to enforce. This is not an area for compromise, which is why LIMS that are fit for this purpose are now used extensively across clinical and pre-clinical drug development.

4. Poor SOP processes

Standard operating procedures (SOPs) are critical to GLP and other regulatory requirements. Inconsistent application of procedures in clinical and pre-clinical labs can jeopardize progress toward development and commercialization.

Increasingly, electronic SOPs (ESOPs) are a lab’s defense against staff violating procedures. With SOPs defined in a LIMS, for example, a rigid workflow exists with clearly defined technical corrective actions that ensure consistency and adherence to protocol.

5. Instrument incompatibility

The best approach to ongoing instrument calibration and maintenance is a disciplined one, and this is once again where drug companies must rely on technology. Instruments must be able to fit into existing SOPs, handle throughput, undergo constant and rigid validation and, equally important, be on predefined maintenance schedules that ensure consistency and data integrity.

Sweat the small stuff!

From assay validation, bioanalysis of samples and sample tracking to reporting of results, research requirements in pre-clinical and clinical labs are onerous. In their haste to accelerate and simultaneously achieve compliance, many drug companies overlook the obvious. LIMS were designed to correct this, but many companies either don’t have a system built for purpose or it’s not configured as it should be. Let your LIMS help you manage the everyday problems so you can focus on identifying the next major compound discovery.