Approach: Methodology


The Tribiosys Solutions Methodology - the foundation of each client engagement - is an established, quality-driven process based on an integrated set of deliverables that build on each other incrementally to deliver solutions quickly. The process is flexible enough to consider each client's specifics without sacrificing a rigorous quality framework.

The Tribiosys Solutions Methodology Suite includes the following components which are represented in the graphic below:

Click on image for larger view

Tribiosys Strategy Offerings:

Tribiosys’ has a unified strategy offering that spans all the Practice Areas utilized by clients wishing to elaborate, plan, prioritize and budget for downstream projects which could yield quick returns on the investment. We conduct strategy workshops at various levels tailored to meet our clients’ needs and budgets.

Some examples of the use of Tribiosys’ Strategic offerings include:

1. Business, scientific and technical process identification and optimization.
2. Scientific data integration strategy, application integration and middleware technology selection and     planning.
3. Commercial Off The Shelf (COTS) product identification and selection including RFP generation and     management.
4. LIMS integration planning.
5. Regulatory compliance (21 CFR Part 11 etc.) and Validation (IQ, OQ, PQ) assessment and     remediation planning.
6. Requirements gathering from multiple groups and stakeholders.
7. Generating Use Cases, functional and technical specifications, UI Screen mockups and other design     documents.
8. Enterprise project identification and planning.
9. Business case generation and ROI estimation.

  Our approach is consistent for every strategy engagement but the workshops will differ depending on   the project scope and are tailored to suit client needs. The Strategy Offerings are available at three   levels:

High-Level Discovery Workshop Strategy Offering
  This discovery workshop usually lasts one week and areas of concern are covered with IT and the   stakeholders (clinical, regulatory, scientific etc.). Requirements are gathered with the input of the   stakeholder experts and assessments are made at an appropriately high level. This type of strategy   engagement is appropriate for companies wishing to verify their existing plans or to make a case for   further initiatives.

Broad-Based Strategy Offering
  In this workshop the requirements, assessments and recommendations are covered in detail with all   interested stakeholders over a four week period. Architecture plans are covered in detail and   candidate projects with an accompanying roadmap are produced.

In-Depth Strategy Offering
  This strategy engagement is used by companies wishing to undertake a top-to-bottom analysis of their   processes and data flows. User groups are consulted in detail and extensive planning and business   case analysis takes place. The usual timeframe for this engagement is eight to twelve weeks.
  In this workshop the requirements, assessments and recommendations are covered in detail with all   interested stakeholders over a four week period. Architecture plans are covered in detail and   candidate projects with an accompanying roadmap are produced.


A Phased Approach

  All three of Tribiosys’ Strategy Offerings use a phased approach to identifying, validating and designing   solutions. Each phase utilizes relevant scientific, clinical, regulatory, business and technical resources   to develop the specific deliverables required of that phase.



Business Drivers
  In this phase the business requirements are identified by the users and stakeholders in facilitated   sessions. Depending on the length of the engagement, multiple rounds of requirements validation may   be performed and the project stakeholders are consulted with to prioritize the business drivers.

Current State Assessment
  Current processes and data flows are identified, analyzed and mapped. In addition current systems in   use are assessed and their interaction with the data flows and processes are determined.

Future State Recommendations
  Optimizations to existing processes and data flows are recommended and a system and architectural   plan is created. In longer engagements the level of detail includes inter and intra-group process   optimizations as well as detailed architectural plans that complement current enterprise technologies.

  The roadmap consists of candidate projects mapped to an agreed timeline. Dependencies, risks and   budgetary factors are explained. The business case is presented and costs as well as potential returns   on investment are calculated.

Example: Discovery Workshop Strategy Offering

High-level discovery workshops usually last one week and participants mostly consist of science,clinical, regulatory and IT stakeholders. Each day has a specific goal and the approach is geared   towards the efficient gathering of requirements in the short time allotted. The following explains the   day-by-day activities and deliverables of a discovery workshop.

Pre-kickoff Period
Before any workshop can begin a point-of-contact or project manager on the client side must be identified. This person is responsible for coordinating schedules, ensuring the appropriate stakeholders are available and booking meeting rooms at the client site if necessary. An agenda and schedule for the week is then drawn up.

Day One
The Tribiosys team prepares the necessary workshop material including a questionnaire that will be completed by stakeholders. Alternatively a discussion topics list will be drawn up. Both of these documents are used to discover requirements in order to determine the critical success factors. The team will also review any previous pertinent assessments as well as appropriate existing material such as process flows and system architectures. The questionnaire or discussion topics list is distributed before the end of day.

Day Two
Meetings with the appropriate stakeholders take place, usually individually to ensure better scheduling. The questionnaire/discussion topics list is used as a basis to gather pressing requirements and identify key business drivers. Executives are often consulted in a brief but focused visioning and strategy session. A functional requirements JAD session usually takes place in the afternoon.

Day Three
The process flows are mapped by the Tribiosys team and later validated with the appropriate stakeholders. Existing system architectures are also examined and future state enhancements are considered while keeping in mind the corporate enterprise technology vision.

Day Four
The material from the previous three days meetings are assembled and analyzed. Potential solutions and improvements are discussed and any outstanding points of concern or clarification are resolved. The final deliverable is prepared.

Day Five
The implementation roadmap, possible vendor recommendations and overall deliverable are finalized. A formal presentation of the discovery workshop findings and recommendations is held. An open discussion is encouraged and next steps are determined.

•  Interview summaries and meeting minutes
•  Critical Success Factors
•  Key Business Drivers
•  Prioritized high level requirements
•  System architecture options
•  Possible product vendor recommendations
•  Overall solution options and presentation
•  Phased implementation roadmap

© 2004-2006 - All rights reserved