Services

EmpiriStat provides a wide range of services throughout every project and clinical trial phase. Some services— such as statistical programming of table, listing and figure shells—provide a cost savings if programmed and validated while the trial is ongoing (instead of during the database closure and analysis phase). The range of our services can be categorized loosely by project/trial phase as follows:

Planning and Preparation Prior to Clinical Trial Initiation

• Provide statistical and study design expertise
• Protocol development and writing including statistical sections and sample size and power calculations
• Protocol scientific and statistical review
• Randomization plan development, writing and implementation
• Maintenance of blinding and unblinding plan documentation and review
• Statistical analysis plans with table, listing and figure shells
• Investigator Brochure summary of data, presentation, writing and review
• Data and Safety Monitoring Board (DSMB) statistical report shells

Implementation Phase

• Statistical programming specifications writing and review
• Statistical programming in SAS®
• Statistical programming validation
• Interim data monitoring and analysis

Database Closure and Analysis Phase

• Database review and cleaning
• Clinical review programming
• Primary statistical analysis and secondary review of statistical analyses and interpretation
• Statistical reports and interpretation of results
• Create presentations of statistical results for study reports, oral presentations, and publications
• Present and publish study results as applicable

Post Clinical Trial Phase

• Abstract and publication analysis and preparation
• Integrated Summary of Efficacy (ISE) plans and analyses
• Secondary review of ISE plans and analyses
• Integrated Summary of Safety (ISS) plans and analyses
• Secondary review of ISS plans and analyses
• Final clinical study report analyses, writing and review
• Pharmocovigilance programming and assistance

Ongoing

• Statistical review and commenting for regulated documents, packets, filings and submissions
• Statistical representation at regulatory meetings, including the FDA
• Macro validation
• IND annual report analyses, writing and review
• Attend FDA meetings and conference calls with client, formulate questions and provide assistance with written responses
• Assist with FDA meeting packets, IND, NDA and BLA filings

General

• Statistical standard operating procedures, work instructions, and templates
• Unblinded statistician services for data and safety monitoring boards, prepare analyses, reports and present at DSMB, minutes recording during closed sessions

Establishing, managing and participating on a Data and Safety Monitoring Board is a serious process.  EmpiriStat has the skills, knowledge and experience to perform DSMB services professionally and effectively.  As a partner in the process, our professional management and secure data analysis and delivery ensures the following:

• Leadership to assist with establishing the objectives, responsibilities and procedures through an official charter
• Expertise to establish procedures for the review of safety data and fully qualified to act as the unblinded partner in performing the statistical analysis
• Provide restricted and protected access to information
• Facilitation of the exchange of information between the DSMB members, chair and sponsor
• Collection of data from laboratories, safety departments, sponsor trial databases, event committees, ECG readings and other data sources

EmpiriStat has the expertise and capability to succeed at collaborating and managing overall projects and clinical trials beyond biostatistical services; as part of your Sponsor Team. Many clients find that adding our Principal Biostatistician, Dr. Close to your Sponsor team, you have the leadership and oversight of your Biometrics vendors that goes often without check. Our oversight of CROs and vendors includes...

• Review contracts with vendors for DM, Stats for deliverables, timelines, and most importantly any missing items from the contract
• SME review of DM, Stats and Programming Vendor SOPs. Identify gaps for study specific processes needed for this protocol; write and put in place with Vendor before study starts
• Request and review a dummy Randomization File, sign-off on Randomization specifications
• Test Randomization system prior to production and release
• EDC and database set up, timelines, testing and approvals
• Review Edit Specifications, test Edit Checks, and review Manual Query process
• Review and comment on Data Management Plan
• Review and comment on the Data Transfer Specifications (DTS) documents for each Vendor providing data collection and transfer
• **Laboratory Testing Timelines and Data Transfers (most labs are testing for COVID and are delaying all clinical lab sample testing by weeks).
• Review and Approve Data Management Sponsor Progress Reports and schedule of such updates
• Review and Approve Biostats and Statistical Programming Sponsor Progress Reports and schedule of such updates
• Data Monitoring processes, cleaning and timelines
• Review Clinical Monitoring Plan and Rolling Data Freezes/Subject Data locks
• DMC Charter and DMC Charter documents review and comments
• Review CDISC coding principles by CRO;
  • Review SDTM specifications and approve
  • Review ADaM specifications and approve
• Review SAP and Mock TFLs, manage timeline
• Program and validate the Primary endpoint analysis to verify for Sponsor coding was correct

Effective and well-executed data management is a vital part of any project or clinical trial, and EmpiriStat’s guidance of clinical data management ensure the quality of your results.

• We offer three different EDC platforms to use for your trial, selected based on study requirements
• Design and review of case report forms
• Design data structures appropriate for clinical and laboratory data
• Data Managers for your project
• Review of protocol documents and study manuals
• Write and review data management plans and edit specifications
• Provide edit specification programming and validation
• Querying and review
• Clinical Monitoring reports