Data management

Lambda-Plus provides integrated Clinical Data Management services from study design to study close-out:

1. Study setup

  • Input in CRF design
  • Creation of annotated CRF
  • Data Management Plan (DMP)
  • Data Cleaning Plan (DCP) & Programming
  • Data Validation Plan (DVP)
  • E-Platform setup (incl. eCRF/ePRO/IWRS), testing & validation
  • Data exchange with external data sources and systems (in/out)
  • ECRF completion guidelines

 

2. Study conduct

  • E-Platform and database hosting
  • Handling reference ranges
  • Data integration
  • Data Cleaning Process
  • (Risk-based) Data Monitoring through vertical and longitudinal analysis
  • Data exports

 

3. Study close-out

  • Data reconciliation across multiple sources and systems
  • Database lock, transfer & archiving
  • Data Management Report

Biostatistics and medical services

Lambda-Plus offers integrated Biostatistics and Medical services from study design to study close-out.

We guarantee quality outputs through continuous interactions between Biostatistics and Medical teams

 

Biostatistics

1. Study setup

  • Sample size calculation and justification in protocol
  • Statistical section of the protocol
  • Randomization algorithm and list
  • Statistical Analysis Plan (SAP)
  • Preparation and validation of statistical analysis programs

2. Study conduct

  • Interim Statistical Report

3. Study close-out

  • Final Statistical Report

 

Medical Services

1. Study setup

  • Protocol review/writing
  • CRF review/writing
  • Input to SAP

2. Study conduct

  • Interim Statistical Report review
  • Coding

3. Study close-out

  • Final Statistical Report review
  • Clinical Study Report (CSR)

 

 

Project Management

Project Management is often a matter of people.

Although the human factor plays an important role in project management, we do take the experience and background of the individuals into account before assigning a study to a Project Manager. Assigned projects may be global, regional or national, and project managers may oversee multiple studies.

At Lambda-Plus we also pride ourselves on providing up-to-date training to our Project Managers.

Lambda-Plus Business Project Managers are your first line contact throughout the duration of your clinical trial, from setup to close-out.

Business Project Managers ensure that your project is completed on time, on budget and meets high quality standards. They are in charge of overseeing all relevant activities involved in delivering Lambda-Plus services.

 

Lambda-Plus Business Project Managers' main responsibilities include:

  • First line contact with the client
  • Overall coordination of eClinical services, from project setup to closeout
  • Direction of the technical, protocol-specific and operational aspects of assigned trials
  • Accountability for ensuring all project deliverables meet customers' expectations as well as Lambda-Plus standards
  • Monitoring of agreed timelines
  • Evaluation of fundamental issues on the project, interpretation of data and ensuring the implementation of timely solutions