Analysis & Design Services
Our analysis and design services focus on helping you develop a clear strategy and prepare for the implementation and integration technological infrastructure.
Strategic Planning
Montrium’s knowledge of GxP processes coupled with its in-depth knowledge of the different systems that make up the pharmaceutical landscape enables us to work with your team to implement a coherent GxP IT strategy which focuses on minimizing risk and aligning technology with your existing processes and corporate development plan.
In conjunction with your local teams and key personnel, we can perform an in-depth Gap Analysis of your existing environment and processes in order to define a clear technological road-map in the form of a strategic plan. This plan will focus on standardization and improvement of processes, integration of new and existing technologies, meeting regulatory requirements and improving quality.
User Requirements Gathering
When selecting vendors and computerized systems, it is imperative to ensure that the team has a clear understanding of their requirements. By formally defining requirements, not only are we able to set criteria for vendor selection which are based on exact needs, but also avoid costly mistakes once the vendor has been selected. Montrium’s team of experts is able to work with your operational teams to define clear user requirements which are aligned to your processes and regulatory requirements. To provide a requirements baseline and accelerate the requirements definition process, we offer pre-defined sets of generic user requirements for specific GxP systems such as EDC, CTMS, PV and ERP. These pre-defined requirements are based on industry and regulatory standards and can be adapted to your organizations specific requirements.
Vendor Selection (RFI-RFP)
Montrium will help you manage the Request for Information (RFI) and Request for Proposal (RFP) process in order to select the suppliers delivering the technological solutions best adapted to your organization, strategy and projects.
This process includes:
- Preparation of RFI / RFP documents
- Definition of selection criteria
- Identification of potential suppliers based on requirements and selection criteria
- Evaluation of vendor responses and capabilities
- Vendor qualification and CSV audits
- Organization of vendor bid defense
We provide standard templates and project plans to manage vendor selection based on tried and tested methods.
Project Management
At Montrium project management activities are key to our success in delivering quality services. We have seasoned project managers who work closely with your team to ensure that projects are planned and managed adequately. We use pre-defined, system specific project plans which are based on our experience of implementing various GxP systems and our technology deployment methodology. These project plans are milestone driven and are updated regularly.
Process Re-engineering
When implementing technological infrastructure, there are often opportunities to automate and improve processes. One of Montrium’s core competencies is process re-engineering both in the clinical world and in GMP environments. Our Business Analysts work closely with your internal teams to map out, analyze and automate existing processes. Much focus is placed on increasing value, agility and quality whilst reducing bottlenecks and ambiguity. We have experience in the deployment of business process management (BPM) software such as Microsoft SharePoint foundation or Nintex Workflow which can help drive processes across systems.
System Configuration and Design
Should you need to customize or simply configure and validate an off the shelf system, Montrium’s team of Business Analysts can assist in the development of user requirements and functional specification documents. These documents are based on the GAMP5 standard and are developed with the clients’ internal team and vendors. Specification documents tend to be complimentary to vendor documentation and address sponsor specific operational and regulatory requirements. These documents also form the basis for system selection, configuration and validation.
Standards Development
Montrium helps organizations leverage industry standards both for the integration of systems and exchange of data and documents between systems. Industry standards are becoming increasingly mainstream both for the interchange and submission of clinical data. Montrium has experience working with and implementing the various CDISC and ICH standards including ODM, SDTM, LAB, E2B(M) and eCTD. Through the use of these standards, our clients are able to harmonize systems and data and enable the reuse of data processing modules which reduces the time and resources necessary for systems deployment.
Change Management
An important part of implementing new systems and process re-engineering is change management and ensuring that new infrastructure and work methods are adopted by the organization. It is paramount that individuals are involved in the change process from the outset. To this end, Montrium can help manage the change process within your organization through the mediation of user groups and coaching of individuals responsible for implementing change.
