Biostatistics

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

  • Interim analyses

  • Manuscripts and presentations

  • Submission to regulatory authorities (ISS/ISE, post-submission support, etc.)

  • Periodic safety updates

Statistical Programming with CDISC Standards

Summit Biostats has supported clinical trials of different phases and therapeutic areas, 

And the Summit Biostats programming teams consists of qualified statistical programmers who have experience in various types of trials.

 

Keeping our team up to date on all regulatory standards is very important in order to perform sound data analyses on appropriately set-up data sets.  Therefore, we perform regular training sessions on relevant topics such as CDISC (SDTM and ADaM), ICH, and other agency guidelines. Depending on the client’s preference, we can perform our services on either the customers IT systems or our own systems.

 

Summit Biostats 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:

  • Production of analysis data sets

  • Production of statistical analysis outputs (tables, listings, and figures)

  • CDISC (SDTM and ADaM)

  • Program validation

Regulatory Data Standards

Summit Biostats staff are experts in regulatory data science and the data standards required to comply with FDA mandated standards for submissions. The US FDA now requires standardized data to be submitted with NDAs, BLAs, and ANDA’s. We can help you provide a high-quality submission that will meet FDA’s standards. In addition, we can help with the following.

 

  •  Study Data Standardization Plan (SDSPs) 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. Per this guidance, the development and submission of an SDSP is required with an IND.

 

Summit Biostats supports our clients in 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 standards for submitting animal toxicology, ADME, and non-clinical animal PK/PK data with regulatory submissions.

 

  Summit Biostats staff are experienced in the efficient

  development and validation of CDISC-compliant, fully-

  documented, submission-ready, SEND dataset.

  Statistical Report Writing

We understand a well written study report is critical to presenting study results. We are experienced in working with clinical teams to generate high quality study reports, statistical reports, and manuscripts.  Summit Biostats can fully support clients with writing in the following areas:

  • Study protocols and amendments

  • Statistical sections of CSRs, in collaboration with sponsor medical writers

  • Stand-alone Statistical Reports or Statistical Analysis Reports (SAR)

  • Statistical Analysis Plans (SAPs)

 

In addition to study specific report writing our team supports clients with integrated statistical and writing services to support:

  • Regulatory documents to support meetings and submissions

  • Manuscript preparation

  • Professional meeting preparations (posters and slide decks)

  • Promotional and educational materials for medical education

Data Management

We are a data-driven industry and organization.   This is your clinical trial data that we are collecting and cleaning, and every decision you make in the clinical development process relies on this data being accurate. We provide accurate, insightful clinical trial data management service in the following areas:

 

  • Data Management Plan development

  • Case Report Form (CRF and eCRF) design

  • Electronic Data Capture implementation, site training and support

  • Data receipt, logging, and tracking

  • Data entry

  • Data review

  • Query management

  • Medical coding (WHO Drug and MedDRA)

  • Data quality assurance

  • Data management reporting

  • Secure vendor electronic data transfer and upload

Statistical Consulting

Our Statistical Consulting Services begin by listening and understanding our clients’ product development goals. We deliver a decisive plan that will optimize cost containment, minimize redundancy, reduce project timelines, and achieve short and long-term goals. Our experts will advise you through the implementation process or will take an active role initiating change through our own functional teams. 

 

Our consulting services include

 

  • Protocol/study design

  • Sample size determination

  • Randomization

  • External, independent, unblinded statistician

  • IDMC/DSMB support

  • Regulatory Document review

  • Data standards

  • SOP writing

  • Macro development

  • Data Management