Bio-informatics

At DDL we believe in multi disciplinary teams where we combine the knowledge of PHD grade scientists and senior bio-informaticians in order to create a tailor made pipeline for you.

With our scientific knowledge we are able to provide you a fully GxP compliant pipeline that has been scientifically validated.

We understand the importance of not only generating high quality data but also being able to deliver this data into your own clinical database or provide the output in submission ready formatting to FDA. We can assign a datamanager to your project who will ensure the quality, formatting (CDISC/SDTM) and compliancy of data for you. This makes DDL a unique partner.

DDL has a strong focus on virology and microbiome, therefore we have developed pipelines that we can make available for you to use. We can also tailor our existing pipelines to suite your special needs or develop a tailor made pipeline for you. See below for more information or get in touch with us.

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Custom pipeline development

Based on your requirements we can develop a custom pipeline for you

Projectmanagement

Projectmanagement

Every project has a dedicated projectmanager who ensures scope, planning and delivery of your pipeline. We use an agile project management method.

Pipeline design

Pipeline design

Together with your own scientists we design the pipeline to fit your needs. This is where our scientists come in to assist you on the scope of the project and the specific needs for your type of analyses. We thoroughly describe requirements and will specify this in a statement of work.

Pipeline development

Pipeline development

We develop the pipeline for you, this is a close collaboration between our bio informaticians and scientists. We have broad experience with open source tools and if needed we have the ability to develop a pipeline in Python for you. Our own Athena Virology pipeline is build in python and used by multiple top-20 pharma companies.

Pipeline hosting

Pipeline hosting

After the pipeline has been created you want to make it available to your internal organization (or other stakeholders). DDL offers two options for that:

  1. We can assist you on running the pipeline on your own  environment (on-premise or cloud)
  2. DDL can offer you access to the pipeline on its own secure high performance computing platform.
Pipeline validation

Pipeline validation

Perhaps one of the most challenging aspects of bio-informatics is the validation of the pipeline. At DDL we offer you completely validated and scientific validated pipelines. All software is fully auditable and reproducable. All our systems are GxP and 21CFR part 11 compliant to ensure record authenticity, integrity and confidentiality.

What does this mean?
Our technical implementation is fully documented. For this we follow a risk based approach based on the GAMP5 standard. This ensures that the software is fully documented and technically validated. You receive a extensive validation report.

Second there is the scientific validation. Every pipeline comes with one or multiple scientific validation reports where we prove that the analyses performed by the software is indeed scientifically correct. You receive a extensive scientific validation report.

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Compliancy

GxP & FDA
From our background in assay development and clinical trial support we understand the importance of compliancy. All our pipelines are fully compliant to GxP requirements and are built following the guidelines of the FDA.

Datamanagement
We have a dedicated datamanagement department who can help you in setting up data transfer formats following CDISC standards and setup the output of the data in a compliant format.

Bio Compute Object (Research project)

DDL participates in the FDA and George Washington University initiative of BCO in order to create a standard for the description of data analyses pipelines.

The Athena pipeline is the first virology pipeline that will be BCO described.

DDL works together with Seven Bridges in order to ensure a compliant and reliable platform for your analyses.

We can provide access to our Athena Virology pipeline via the Seven Bridges platform allowing you to run the pipeline on a high performance computing environment. With fully transparant and predictive costs and without any large investments in infrastructure or software.

We take care of the deployment of the pipeline on the environment. That way you can focus on the output and analyses of the data instead of worrying about virtual machines, processors and memory.

Contact us

Just give us a call, send us an e-mail or make an appointment!