We perform full SDLC and PMM responsibilities across various areas including:
•    strategic planning 
•    program and project portfolio management
•    project charter and scope definition
•    business analysis
•    scheduling/resourcing
•    finance/budgeting
•    business process modeling and gap analysis
•    change management
•    systems architecture
•    hardware/infrastructure
•    requirements elicitation, design specifications and full project documentation
•    data warehousing and business intelligence
•    managing in-house and off-shore development teams
•    testing
•    implementation
•    maintenance
•    vendor management

We have extensive experience with comprehensive testing and formal validation of information technology systems in a regulated environment in compliance with guidelines such as GxP, 21 CFR Part 11, MHRA, EMEA, HIPAA, and SOX including validation plans, protocol development, UAT, IQ/OQ/PQ, and traceability matrices.

We have extensive knowledge of and experience with various system development lifecycle (SDLC) methodologies and project management methodologies including: 
•    AGILE/SCRUM
•    RUP
•    PMBOK
•    COBIT
•    ITIL
•    DSDM
•    JAD
•    RAD

Of course, we have extensive experience with standard tools including:
•    MS Office (Word, Excel PowerPoint)
•    MS Project
•    Visio
•    Documentum
•    Oracle
•    SQL
•    Informatica
•    ERwin
•    Business Objects
•    Cognos
•    Crystal Reports
•    Spotfire
•    Tableau
•    JIRA
•    SharePoint
•    SparxEA
•    GSA

We have extensive hands-on experience with industry-standard software package implementations including:
•    Clintrace
•    Clintrial
•    Oracle Clinical
•    TrialManager
•    IMPACT
•    ARISg
•    Argus
•    Veeva Vault
•    WebVDME/Empirica
•    Qscan-ERM
•    Halo
•    SafetyMart
•    TrackWise
•    BIOVIA/CISPro

As information technology initiatives begin and before detailed requirements gathering starts, we've found that it’s important to first address some fundamental questions, such as:

• What are the objectives of your organization? What are you trying to accomplish? What are your top priority business goals?

• What must this project accomplish to be deemed successful?

• How do you measure your effectiveness and what are your success metrics?

• What jobs/functions and departments within the organization are most crucial to ensuring that these key success factors are achieved and what role do they play?

• What are the key business issues you face today? What prevents you from meeting your business objectives? What’s the impact on the organization?

• How do you identify problems/exceptions?

• What do you see as opportunities that are not being addressed today?

• What role does data analysis play in decisions that you and other managers make?

• What key information is required to make or support the decisions you make in the process of achieving your goals and overcoming obstacles? How do you get this information today? How do you know the information is accurate?

• Are there data, reports, analyses, or other information that are not currently available or difficult to obtain that you would like to have more efficient access to?

• Who are your primary internal and external customers for data, reports, and analysis?

• What information do you prepare? Where does the input for this come from?

• What is the current process used to disseminate information?

• Are there specific bottlenecks to getting at information?

• What is the biggest bottleneck/issues with the current data access/generation process?

• How much historical information is required?

• What often goes wrong (and/or) is unpredictable or out of your control in your opinion?

• Which queries/reports do you currently use? How do you use the information?

• What additional queries/reports would you like to have?

• What analytic capabilities would you like to have?

• What opportunities exist to dramatically improve your business operations and processes related to data gathering, generation, access and dissemination?

In our experience, thorough, comprehensive, complete, and accurate requirements elicitation, definition, and documentation are absolutely essential to the success of the project.  Project managers and business analysts must work together to ensure that adequate time at the beginning of projects has been allocated to this critical task.  The seeds of failure are often sown, albeit sometimes unknowingly, during this phase of the project due to poor and incomplete requirements.  (The other danger zone is of course inadequate testing.)

The purpose of requirements in general is to clearly define and specify exactly what a particular deliverable (whether it’s a product, system, application, or service) should be or perform.  Effective functional/user requirements represent the business logic that the software needs to accommodate, and define the key functional processes that the system must support.  The requirements focus on the “what”, while the design concerns itself with the “how”.  A requirement is a statement that identifies an essential characteristic, attribute, capability, or quality of a deliverable in order for it to have value to the user.  Some basic attributes of a good requirement are that it is singular, unambiguous, concise, traceable to business needs, and testable. 

There are various types of requirements including:

Business requirements describe in business terms what must be accomplished or produced in order to provide value to the stakeholders.

User/Functional requirements describe the functionality and capabilities that the system must do, provide or execute.

Non-Functional requirements describe what the system must be; how the system should work or behave.  These can include performance, manageability, reliability, etc. and quality attributes as well.

Technical requirements can refer to several things; they can pertain to the technical aspects that the system must fulfill or adhere to, such as performance and reliability specifications.  They can also be detailed build/code or data specifications necessary for design.

Some additional notable factors that can greatly increase the probability of a successful outcome:

• Possess a very clear vision of our mission, and its strategic importance to the company.

• Avoid the tendency to jump to a technology solution before clearly defining the business problem and first addressing business process reengineering and change management. Throwing resources and technology at an inefficient process will yield automated inefficiency.

• Articulate specific and tangible deliverables with clearly defined business value.

• Go beyond conference room PowerPoint presentations by software vendors "demonstrating" to us how their products meet our needs. Ensure that the project plan calls for full pilot implementations of competing products with actual users performing thorough evaluations by testing an array of diverse and comprehensive "real-life" business scenarios.

• Establish and maintain honest and clear communication with the client to nurture and grow the IT and business partnership based on trust and openness.

• Provide the client thorough and detailed information so that they can make informed decisions and know what to expect in terms of project timeline, milestones, outcomes, and specific deliverables.

• Deliver easy big hits first to bolster team confidence and to show project sponsors quick progress. This will establish an atmosphere of success and accomplishment that will fuel future successes in the later phases of the project.

• Create and maintain formal system documentation throughout the project lifecycle.

• Geography cannot be a boundary; maintain a global perspective from the outset, not as an afterthought.

• Once requirements are defined (see above), beware of scope creep.

Click on these specialties to further explore our other services:
Strategic Guidance
Process Innovation