SmartStartDocument Templates

Tech-enabled templates provide innovative
solutions to document content creation

SmartStart™ Templates, a structured authoring tool and clinical trial template to reduce time and effort in the medical writing process

 

 

MMS strives to bring innovative technologies and processes to accelerate the development of new therapies, and with our line of SmartStart Templates, MMS utilized the technology of structured authoring to reduce time and effort while increasing the quality of deliverables. These tech-enabled templates for protocols, statistical analysis plans (SAPs), and clinical study reports (CSRs) were developed to improve consistency, time-savings, and quality while allowing for the reuse of data across deliverables such as protocol to protocol, protocol to CSR, protocol, to SAP, CSR to CSR, and SAP to SAP. 

SmartStart Templates are proven to reduce human errors by: 

  • Automatically sharing reusable content within and across protocols, SAPs, and CSRs.  
    • Reusable content in the body of the protocol and CSR will automatically update in the synopsis 
    • Reusable content can be imported between documents 
  • Increasing quality and reducing effort  
  • Efficiently presenting reusable content across products, programs, and therapeutic areas 
  • Decreasing review times, allowing reviewers to focus on newly-added content.  

Previously completed protocols can be transferred into SmartStart Templates to take advantage of efficiencies on downstream documents. Sponsors who use these tech-enabled templates will experience increases in consistency and efficiencies for internal teams, sites, regulators, investigational review boards (IRB), and patients. Greater efficiencies can be gained by partnering with MMS at the program level during early phase development. 

Learn the key benefits of each template, as follows:

 

Protocols

Sponsors who use the MMS SmartStart Template for Clinical Study Protocols will see the following benefits 

  • Lean format  
  • Common structure and endpoint definitions accepted by regulators 
  • Proposed model text requiring minimal or no editing 
  • Defined libraries 
  • ICH compliant 
SAPs

Sponsors who use the MMS SmartStart Template for Statistical Analysis Plans (SAP) will see the following benefits:  

  • Common format 
  • Library content is specific for SAPs/SAP documentation 
  • Easily integrates with the MMS Tech-enabled protocol 
  • Consistent with ICH E9 (R1) for Estimand use 
  • Aligns with global regulatory requirements for reporting and disclosure 
CSRs

Sponsors who use the MMS SmartStart Template for Clinical Study Reports (CSR) will see the following benefits: 

  • Lean and streamlined structure 
  • Language consistent with the MMS Tech-enabled protocol 
  • Easily integrates with MMS tech-enabled protocol 
  • Adheres to global requirements 
  • Limits redundancy by referring to appendices 
Request a demo of SmartStart

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Regulatory Affairs & Operations

Data Management & Biostatistics

Regulatory & Medical Writing

Drug Safety & Pharmacovigilance

Compliance & Transparency