Summit 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.
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,
Bioavailability and bioequivalence
Drug interaction studies
Pharmacodynamic and pharmacokinetic/pharmacodynamic modelling and BLRMs
Statistical Programming with CDIS
Summit 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:
Tables, listings and figures
CDISC (SDTM and ADaM) mapping
Implementation of crossover correction methods in SAS
Summit has a strong focus on non-clinical statistics. We interact with regulatory authorities, and we know and work according their guidelines on a daily basis. Companies that want to progress non-clinical projects, and medical device companies within an increasingly regulated environment, can benefit from our experience, such as:
Statistical and analysis planning for medical device trials
Design of Experiments statistical input and recommendations
Interaction with authorities (e.g. FDA, EMA) focusing on statistical design or data analyses
Regulatory Data Standard
Summit Analytical staff are experts in the regulatory data sciences surrounding data standards and compliance with FDA mandated standards for submissions. The United States FDA now requires standardized data to be submitted with NDAs, BLA, and ANDA’s. We develop and provide our clients high quality:
Study Data Standardization Plans (SDSP) for a drug or device development program. On February 17, 2014 the FDA Guidance on Providing Regulatory Submissions in Electronic Format – Standardized Study Data was published as final and binding. In this guidance the development and submission of a SDSP with and IND is required. Summit Analytical supports our clients with the development and maintenance of the SDSP, and ensures that the plan is implemented throughout the life-cycle of a clinical development program.
CDISC compliant Non-clinical SEND : The CDISC Standard for Exchange of Nonclinical Data (SEND) is the standard for which animal toxicology, ADME, and non-clinical animal PK/PD data are to be submitted with regulatory submissions. Summit Analytical are experts in the efficient development and validation of CDISC compliant, fully documented, submission ready, SEND datasets. This service is linked to our biostatistical support for toxicokinetics.
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We offer pharmaceutical, biotech, and medical device companies, the opportunity to take advantage of our biostatistical expertise. In short, we can provide statistical input to study protocols (including advice on the study design), writing or review of statistical analysis plans, and input to clinical study reports, in addition to performing the necessary statistical analyses.
However, we leverage out biostatistical experts to bring technical expertise and efficiencies to projects of all sizes, ranging from small first-in-human studies, to large multinational trials. Our biostatisticians can provide support for clinical development plans or individual study protocols, including study design, sample size determination, delineation of objectives and endpoints, and statistical analysis strategies. Our experienced professionals routinely provide technical support for complex statistical methodology, handling of missing data, and regulatory guidance for strategic planning, and can provide representation at meetings with global regulatory authorities.
All of the analyses and outputs are based on well documented specifications and can be validated via independent double programming. Further, our biostatisticians collaborate with medical writers and scientific experts to ensure appropriate interpretation of study results.
In addition, our biostatistics team (supported by our statistical programming team) can provide full-service support though out all phases of clinical development and commercialization. All of our biostatisticians and statistical programmers are trained in current methods and standards to support the successful execution of your projects.
To summarize, our services include
Assistance with trial design and input to clinical protocols (including sample size calculations)
Comprehensive Statistical Analysis Plans
Randomization plans and schedules
Submission-ready datasets and supporting metadata consistent with industry standards (eg, CDISC, SDTM and ADaM)
Blinded and unblinded tables, listings, and figures (TLFs)
Biostatistical input to clinical study report text
Finally, our biostatistics and statistical programming team can provide complete services for a variety of reporting events including the following.
Independent Data Monitoring Committees
Manuscripts and presentations
Submission to regulatory authorities (ISS/ISE, post-submission support, etc.)