Statogen Consulting supports companies develop and execute their biopharmaceutical and medical device product strategies by combining innovative research, development and international submission expertise.

By applying innovative solution tools, such as process optimization, adaptive designs, and metrics, we help our clients and partners maximize returns on their Research and Development investments and accelerate the delivery of safe and effective therapeutics to patients faster and at a lower cost.

Statogen Consulting is owned and operated by Dr. Stephan Ogenstad and is personally involved in each key expertise area (see below).

Key Expertise Areas:

Program development advise, strategy and consulting phases I-IV
Statistical representation and presentation to regulatory authorities (FDA, EMEA)
Data and Safety Monitoring Board (DSMB) interim analysis planning and statistical support Clinical process innovation - trial design and trial conduct
Clinical trial design, simulation and monitoring system, through adaptive design and analysis
Expert statistical support for individual studies and programs
Statistical methodology review
Analysis interpretation
Report review
Statistical reports
Statistical Analysis Plans
Support in implementation of Critical Path Opportunities
Exploratory analysis
Modeling and simulation
Nonclinical and preclinical consulting
Statistical programming using SAS, East, StatXact, ExpDesign Studio 5
Clinical Trials Methodology from a Statistical Point of View
Biostatistics for nonstatisticians
Adaptive designs
Basic Training Course in Drug Development
Good Clinical Practices

Program Planning

Statogen Consulting can help assess your existing company product development strategy; inclusive of screening new product concepts, evaluating nonclinical and clinical data, determining product need, and identifying regulatory hurdles. In addition, Statogen Consulting will review your nonclinical and clinical data and documentation for evaluation of Phase II and Phase III remedies.

Statogen Consulting recommends full sequences of Phase I-II-III clinical trial designs and adaptive considerations in recognition of the needed critical information in order to proceed most efficiently to product approval. Based on our experiences, this is best done with the FDA and EMEA guidelines as well as historical paths to approval.

Study Design and Analysis

Study planning usually begins with research on the clinical setting of the product: the therapeutic principles, FDA guidance documents including product history, background literature, competing product labeling and summary bases for approval, as well as timelines and resources. A key to flawless design and analysis of clinical trials occurs as a fusion between clear formulations of hypotheses, endpoints, design, analysis, pre-study simulations, statistically controlled adaptation during study conduct, and high quality data. Close collaboration with the Compliance, Medical, Clinical, and Biometrics groups leads to defined project plans for monitoring, safety reporting, data management, analyses, and quality assurance. Responsibilities for the design and analysis can be shared with the Sponsor.

Statogen Consulting can assist in planning and designing your device, drug or biologic program. Our experience spans a number of therapeutic areas.

Statogen Consulting's involvement in Study Design and Analysis Activities Include: Defining the study hypothesis and endpoints Proposing the most efficient and pragmatic design Justifying and exploring cost/benefit scenarios for sample size Writing the Protocol Organizing investigator meetings Writing Statistical Analysis Plan (SAP) and Interim Analysis Plan (IAP) Performing Analysis Planning

Nonclinical Statistics

Statogen Consulting provides consultation and statistical advice in quantitative, experimental design, and data management issues. We are experienced working with scientists, engineers, and others in drug discovery, nonclinical testing, process and product development, and quality control. We have many years of experience in statistical activities such as, design and analysis of animal testing for drug efficacy, pharmacokinetics, toxicity, and bioanalytical assay development.

Data and Safety Monitoring Committees (DSMB)

All clinical investigations, toxicity, and dose-finding studies, efficacy studies, effectiveness and comparative trials involving greater than minimal risk to participants are, at a minimum, required to develop a data and safety monitoring plan to assure the safety and welfare of the research subjects.

Statogen Consulting's DSMB management experience provides the necessary guidance in the establishment and management of DSMBs specific to each sponsor's area of development.

Statogen Consulting recognizes that effective performance of the DSMB is supported by careful tracking of all data, timely information flow between groups, and protection of the integrity of the clinical trial. We understand that the decisions leading to recommendations that our clients continue, modify or terminate trials have a significant impact on the development of products, as well as the responsibility to ensure the safety of each study subject.

DSMB Services: Charter development Statistical representation on DSMB Interim analysis planning and statistical support Meeting structure coordination and management

We approach our work with the goal to ensure that basic scientific discoveries translate more rapidly into new and better medical treatments by creating new tools and methods to find answers about how the safety and effectiveness of new medical products demonstrate in faster time-frames with more certainty, at lower costs, and with better information.

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