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By: Sonia Norris, Medical Writer
Clinical laboratory science (CLS) is an interdisciplinary field that involves setting up, qualifying, validating and performing laboratory assays on human samples to provide the reliable information required to effectively diagnose disease, monitor treatment and assess immune responses (to vaccines, for example).
Accurately reporting such practices remains key to the continuous development and transparency of the field. Nevertheless, this remains a lesser-known area within the remit of life sciences—dedicated to a subset of highly specialized scientific writers, or CLS writers.
So what is CLS writing exactly, and why is it important?
CLS writers report on a significant and extensive part of a laboratory assay’s life cycle, from its set-up to its validation—applicable to the early-to-medium term development stages of a clinical trial. In doing so, they write a wide range of documents that aim to demonstrate to stakeholders involved, including regulatory authorities, that an assay is optimally designed and adequate for clinical testing for its intended use. These include set-up, qualification and validation protocols and reports, responses to questions from authorities, standard operating procedures and briefing documents (i.e. ad hoc documents presented to authorities such as the FDA, including approval requests for a new assay application or strategy, and primarily in the context of a pre-investigational new drug [pre-IND], ”Type C” meeting, scientific advice or IND amendment).
The Modis Life Sciences team of CLS writers: who are we and what is our goal?
At Modis Life Sciences we have a team of scientific writers dedicated to and trained in CLS writing from across the globe. We have emerged from diverse scientific backgrounds, including pharmaceutical science, neurosciences, bioengineering, agronomy, immunology, genetics and biochemistry, and continuously strive to achieve the highest degree of transparency, accuracy and excellence:
Transparency – because we report all applicable analyses and conclusions from all experiments, including any deviations from planned protocol, and abide to all applicable international, ethical and scientific quality standards, including good clinical and documentation practice.
Accuracy – because we write documents and review our colleagues’ work with a critical mindset and in an informed and objective manner at all times.
Excellence – because we have the opportunity to work on and be trained in a wide range of laboratory assays, from immunological assays to cutting-edge multicolor flow cytometry, gaining more expertise by the day.
We are eager to help meet the ever-growing needs of our clients in today’s fast-paced CLS environment. We are motivated by continuously interacting with different teams of experts, and by sharing our technical expertise and in-depth knowledge of the pharmaceutical industry with our clients.
– Sonia Norris, Medical Writer