Clinical Statistics

Staburo offers pharmaceutical/biotech companies, contract research organisations, and medical device manufacturers the opportunity to use our statistical expertise.

Our expertise ranges from the design of clinical phase I-IV trials (statistical input to study protocols and writing of statistical analysis plans) and data analysis, to the independent validation of essential study parts, such as the primary study objectives with SAS double programming. Our statistics experts supported numerous clients in submissions to FDA and EMA.

We have solid experience in oncology (RECIST) and complex study designs (e.g. adaptive, Bayesian BLRM, outcome depending switching/crossover, biomarker) and the implementation of complex methods in macros (RPSFT, IPE, IPCW). We have set up a simulation toolbox in SAS to find the optimal design and to verify the performance of methods and macros. Our toolbox is also useful for developing custom-fit translational research trials and analyses strategies.

Staburo supports pharmaceutical companies with data preparation for public disclosure on clinicaltrials.gov, EudraCT and other registers.

With the implementation of CDISC standards, cross analysis between data sets and traceability can be guaranteed. If necessary, we consult on the anonymisation of clinical data.

Our team members are up-to-date on the EU data transparency legislation, because we participated in public disclosure initiatives for different clients.

We support biosimilars development programs, which play a crucial role in delivering biological medicines to a huge amount of patients. Depending on the client’s needs, we also work on-site for requested periods.

Clinical Statistics Staburo

Translational Medicine & Biomarkers

Translational Medicine & Biomarkers Staburo

An important challenge in future drug development is to provide targeted solutions tailored to individual patients (“Precision Medicine”).

Translational medicine plays a key role in the biomarker guided recommendation of suited therapies. Combining knowledge from basic research with advanced statistical methods, the goal is to identify patient populations that are more likely to benefit from a therapy or that will show fewer side effects.

We provide our customers with comprehensive support in all phases of biomarker-related activities. Our expertise includes

  • Development of protocols and statistical analysis plans
  • Analysis of high-throughput biomarker data
  • Identification and validation of biomarkers using complex statistical models
  • Application of innovative study designs
  • Statistical support for assay validation

 

Statistical Programming with CDISC

Staburo has supported clinical trials of different phases and types. The Staburo programming team consists of qualified statistical programmers, which have been involved in studies of different scales. Keeping our team up-to-date on all regulatory standards is very important in order to perform sound data analyses. Therefore, we perform regular training sessions on relevant topics, such as CDISC (SDTM, ADaM), ICH, and agency guidelines. Depending on the client’s preference, we perform our services on the customer’s IT or our own systems. Staburo programmers support our clients in the development and validation of outputs for clinical study reports and submission ready deliverables. We offer a range of statistical programming services, such as:

  • Analysis datasets
  • Tables, listings and figures
  • CDISC (SDTM and ADaM) mapping
  • Program validation
  • Biomarker identification
  • Implementation of crossover correction methods in SAS
Statistical Programming with CDISC Staburo

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Pharmacokinetics/-dynamics

Pharmacokinetics/-dynamics Staburo

For pharmacokinetic analysis we use WinNonlin® software and SAS. Our PK services are especially interesting for customers, who develop generic/biosimilar medications or clients that perform early clinical phases of new products. We give input to the study design for:

  • Noncompartmental pharmacokinetics analyses and compartmental pharmacokinetics/simulations,
  • Ascending dose
  • Repeat dose
  • Bioavailability and bioequivalence
  • Drug interaction studies
  • Pharmacodynamic and pharmacokinetic/pharmacodynamic modelling and BLRMs

Health Technology Assessment

Staburo supports clients in the planning phase and conduct of HTAs, as well as in reimbursement of drugs and medical devices. We consult on trial design for comparative effectiveness and the selection of surrogate endpoints that can replace clinically relevant endpoints. Staburo performs crossover-corrections, in-depth QoL analyses, indirect comparisons, and meta-analyses to support clients in the interaction with HTA bodies such as IQWiG/GBA or NICE. Staburo has supported various successful HTA projects that have led to a recognition of additional benefit of our client’s products.

Health Technology Assessment Staburo

Medical Devices

Staburo is focused on biostatistics and we interact with regulatory authorities and work with their guidelines on a daily basis. Medical device companies can benefit from our experience, such as:

  • Statistical and analysis planning for trial protocols
  • Input to study design: sample size calculations and power analysis
  • Trial randomisation
  • Medical device data analysis and reports (e.g. for regulatory submissions)
  • Interaction with authorities (e.g. FDA, EMA) focusing on statistical design or data analyses
  • Collaboration with medical device companies to extract all relevant statistical information for regulatory submissions
  • Statistical analysis and preparation of statistical sections for reports, including creation and validation of datasets, tables, and listings for clinical trials

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Services

Expert tasks

Staburo services include advanced statistical support, such as:

  • Consulting on statistical issues
  • Crossover correction in oncology (IPCW, IPTW, IPE, RPSFT methods in SAS macros)
  • Statistical models for high-dimensional genomic data
  • In-depth QoL analyses
  • Multiple imputation
  • Presentations and statistics workshops
  • Data transparency (ClinicalTrials.gov, EudraCT)
  • Bayesian Methods (e.g. BLRM for dose escalation, Safety evaluation)
  • Adaptive designs
  • Data simulation

Writing

Staburo supports you if you need statistical input to trial related documents, e.g.:

  • Protocol input
  • Statistical analysis plan writing (SAP)
  • Statistical report and publication writing
  • Preparation of submission documents (e.g. CSR, CO, ISE, ISS, IB, SmPC, PBRER)
  • Agency interactions
  • Preparation/input to HTA appraisals (e.g. NICE and IQWiG)
  • Statistical expert reports
  • Statistical input to translational medicine projects

Clinical trials

Staburo has a very strong focus on statistics for clinical trials and performs these specific tasks:

  • Clinical trial planning (phases I-IV)
  • Trial and project statistician tasks
  • Sample size calculation
  • Randomisation (including emergency envelopes)
  • Statistical programming with SDTM and ADaM (SAS, R)
  • Validation (e.g. SAS: source code review, double programming)
  • Interim analyses
  • Survival analysis

 

Therapeutic areas

Staburo has worked in many different therapeutic areas:

  • Oncology – strong focus
  • Respiratory – many projects as preferred provider
  • Allergology
  • Cardiovascular
  • Central nervous system
  • Dentistry
  • Dermatology
  • Gastroenterology
  • Gynaecology
  • Haematology
  • Immunology
  • Infectious diseases
  • Metabolic
  • Ophthalmology
  • Pneumology
  • Surgery

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