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BCDS Services

Biostatistics and Clinical Data Sciences

Introduction

The Biostatistics and Clinical Data Sciences Department is integral to the success of our clinical research programs, providing expert statistical analysis and comprehensive data management to drive evidence-based decision-making. Our team of biostatisticians and data scientists collaborate closely to design, analyze, and interpret clinical trial data, ensuring the highest level of scientific rigor and accuracy.

We specialize in developing robust statistical methodologies and innovative data solutions that enhance the quality and reliability of our research. From study design and data collection to advanced analytics and regulatory submissions, we ensure that every phase of the clinical trial process is supported by precise, reliable, and actionable data.

By integrating cutting-edge statistical techniques with state-of-the-art data management practices, BCDS plays a critical role in advancing clinical research, ultimately contributing to the development of new therapies and improved patient outcomes.
  • Therapeutic areas: Oncology, Respiratory, CNS, Infectious diseases (including vaccines), Cardiovascular, Metabolic diseases, Retinal health, GI disorders, Pain, Gene Therapy, Immunology
  • Board members of PHUSE, MedDRA, CDISC, EFSPI, PSI and other organisations
  • Experience working with other clients (pharmaceutical) and other industrial areas
  • In addition to our expertise in clinical statistics, we also support pre-clinical and animal health
  • HTA support including submissions for new EU HTA dossiers
  • Our worldwide network enables immediate availability
  • Versatile associates (functional, time zones and working hours)
  • Excellent retention of associates – years upon years of experience at our fingertips
  • Excellent planning, project management and communication skills
  • Agile working

Our Strategy/Objectives

Elderbrook’s customized approach simplifies complexity through a range of flexible solutions. Whether it’s staff augmentation or the creation of strategically aligned functional teams, our models are designed to seamlessly integrate with your operations—using either your systems and SOPs or ours.

We go beyond being just a partner; we act as your strategic ally, ensuring you have the skilled personnel you need, exactly when you need them. With a strong focus on quality and scalability, we’re fully equipped to meet the intricate demands of your clinical research, empowering you to move forward with confidence.
  • Full outsourcing of data management and statistical analyses tasks for selected trials. This means that all functions (Trial Data Manager, Trial Programmer, and Trial Statistician) will be supported.
  • Partial outsourcing, we can take responsibility at any point in the process (e.g. from SDTM creation).
  • Outsourcing of dedicated tasks to support peaks on short term notice. This means work packages (e.g. set-up of edit checks, programming of Table Listing Figures TLF, support writing Statistical Analysis Plan) will be supported.
  • FSP support, take specific functional roles for a study in cooperation with the trial team (e.g. Study lead data manager, statistician and programmer).

Data Management

Empowering Precision with Data-Driven Insights

At the forefront of our pharmaceutical innovations, the Data Management Department plays a critical role in ensuring the integrity, accuracy, and accessibility of clinical data.

Our team of dedicated professionals is responsible for the collection, organization, and maintenance of high-quality data throughout the lifecycle of clinical trials

We leverage advanced data management technologies and industry best practices to streamline processes, reduce redundancy, and ensure compliance with regulatory standards. By transforming raw data into actionable insights, we support researchers, statisticians, and decision-makers in delivering safe, effective treatments to patients worldwide.

Our commitment to excellence in data management ensures that every piece of information is handled with precision and care, contributing to the success of our clinical programs and the advancement of medical science.
  • Experienced, Lead Data Managers/Engineers
  • RAVE, Oracle Clinical, Veeva CDMS/CDB (and many others), Jreview, JUMP
  • From Protocol input to Database Lock and everything in between (eCRf specification, testing, production, edit checks, DTAs, cleaning, listings, reconciliations, aCRF, SDRG etc.)
  • All Therapeutic Areas with experts in Oncology, Diabetes, Hypertension (Metabolism), COPD (Respiratory), CREA
    SDTM Experts including mapping and transformation/define.xml
  • Pinnacle 21 Enterprise (P21E)
  • QC of submission packages
  • SAS experience
  • Delivery of 150+ quality databases

Statistical Programming

Turning Data into Insight by coding with precision and delivering with confidence

Statistical programmers provide the insights that help plan and design clinical trials , ensure conduct runs smoothly and report and package the findings for all types of publication and submission documents.

We have over 100 statistical programmers spread across the globe to help us provide a 24/7 support network and can provide teams in all time zones to support and work alongside your business needs.

  • We follow the industry standards/trends and evolve new best practices so that we can better support our partners and provide you with state-of-the-art techniques and methodologies.
  • We have the network and experience to quickly resource any studies or provide any  additional support you may need to deliver your submission ready reports.
  • We pride our selves on our quality and make sure we have the correct expertise and geographically based teams available to support your organization.
  • We are structured in a way that allows us to either integrate into an existing team or to provide you with an independent team.
  • We have four levels of oversight to ensure we consistently deliver high quality and timely deliverables. As well as help develop our collaboration and steer our partnership to success.
  • We have a broad background in all statistical programming languages, but we have a high focus on R , Python and SAS.
  • Production of safety and efficacy analyses for regulatory submissions and publications
  • Creation of SDTM, ADaM and TLFs
  • Submission Support (BIMO , CLINSITE and Post Submission Support)
  • In house macros/tools development
  • Standards Library creation and maintenance
  • Safety monitoring, interim analysis and reporting
  • Exploratory and meta-analysis
  • Integrated Summary of Safety / Integrated Summary of Efficacy
  • Support Quality Monitoring, Data Monitoring and Scientific Steering Committees
  • Environment and Software build
  • Data Visualization and R-Shiny applications / tools
  • HTA Dosier

Biostatistics

Statistical Excellence Driving Innovation

Our team of Biostatisticians is at the core of evidence-based decision-making in clinical research. We provide comprehensive statistical expertise, from study design to data analysis, ensuring the scientific rigor and accuracy of our findings.

Our team of skilled biostatisticians collaborates closely with clinical researchers to develop and apply robust statistical methodologies that drive meaningful insights and support the advancement of medical knowledge.

We are committed to delivering precise, reliable, and interpretable data that underpin regulatory submissions, guide clinical development, and ultimately improve patient outcomes. By leveraging advanced statistical techniques and industry best practices, we contribute to the success of our clinical programs and help shape the future of healthcare.
  • Leading all statistical activities in the preparation, conduct and analysis of Phase I to Phase IV studies
  • Sample size calculation using different tools (including EAST, nQuery and R)
  • Study simulations to evaluate operating characteristics of study designs for the planning of new studies
  • CTP writing and review
  • Choice of endpoints
  • Expert knowledge on Estimands and their implementation
  • SAP writing and TFL shells
  • Handling of missing data, including for example multiple imputation and tipping point analysis
  • Adaptive designs
  • Experience in SAS and R
  • Bayesian analysis
  • Writing of statistical sections of the clinical trial reports
  • Results disclosure for ct.gov
  • Writing of articles and posters
  • Training on statistical topics for statisticians and non-statisticians
  • Consultancy and authoring of templates and standard operating procedures for clients
  • Participation in safety reviews as independent statistician
  • Experience in NDA submission related work (FDA, EMA, Japan and others), including Advisory committees

Request a consultation

We invite you to contact us for cooperation and are always looking forward to new opportunities. You can select the topic of your request on the contact form. 

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elderbrook solutions GmbH
Sky Tower
Borsigstr. 4
D-74321 Bietigheim-Bissingen
Tel +49 7142 339 2919
Fax +49 7142 339 5499
info@elderbrook.de

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