Business Consultancy

We will analyze your situation and will identify the technical solution that fits your needs. According to your requirements we implement, validate, introduce and operate the system for you while keeping the burden in your organization low and ensuring to meet your timelines.

Requirement analysis

You do not need a new system for every challenge. How can you make best use of the existing technology? How can you combine your available systems in the best way and where is a need to develop or purchase something new? We will listen to all stakeholders, analyze the existing environment and help you to make the best decision for the use case.

Systems integration

We have history of systems integration of different eClinical systems: EDC to data management, EDC with IxRS, Trial portals with eTMFs, and data management systems with CTMS. We are happy to offer you the benefit of our many years' experience.

System/Vendor selection

We know the eClinical world, we have worked with many vendors and we listen to your needs. We will help you through the maze of solutions and technology.

Optimizing Business Processes through Technology

  • Data Management and Biometrics
    • Electronic data capture systems (EDC)
    • Clinical data management systems
    • Statistical computing systems
  • Clinical Operations Systems
    • Clinical trial management systems (CTMS)
    • Patient randomization and drug supply systems (IxRS: IVRS and IWRS)
    • Risk management and risk monitoring systems for clinical studies
  • Document management and document workflow
    • Clinical trial portals (CTP)
    • Investigator Site Files (ISF)
    • Electronic Trial Master Files (eTMF)
    • Electronic Submissions (eCTD)
    • Identification of Medicinal Products (IDMP)
    • Archiving and Retention
  • Compliance and Competency
    • Learning Management Systems (LMS)
    • Quality Document Management Systems (DMS)
    • Training Programs and Competency Management
    • Adoption of systems to changes in regulations

Computer Systems Validation

We guide you through the paths of compliance. We know the requirements by the regulations (GxP, CFR 21 part 11 & 820, ISO 9001, ISO 13485, ISO 14971) and we know how to validate systems and processes (GAMP 5).

Change management, SOP adoption and writing

Once a new system hits an organization the change has to be managed. Communication, training and process adoption – we have standard processes to change, plans for migration from old to new, and we use your resources carefully.

Risk Management in Clinical studies

Maxclinical has been awarded a grant of the German government to develop risk management systems for clinical research. Let us share our expertise and knowledge.

eClinical Operations

EDC study setup and data management

We have done EDC and data management for over 15 years. We will do you study with a qualified vendor either chosen by you or selected for your special need.

Configuration of Software and Interfaces

Being experienced programmers we will create the interfaces your systems need to talk to each other.

IT Project management

For your IT projects we will deploy our own, proven project management tools and guarantee complete control across the project cycle as well as transparency about milestones and risks.

  1. Change management
  2. Implementation
  3. Validation