Our Expertise

Pharma Initiatives specializes in designing, building, and optimizing clinical development and medical affairs operations.

Deliver results faster and with less effort through process refinement.

Process Optimization

Conduct a value-driven system selection, support the configuration of the
selected system and support the rollout of the system to ensure the expected
benefit is achieved.

System Selection and Implementation

Develop an organization design to achieve business goals, while building positions and capacity plans that bring the minimum number of the right resources to the business as they are needed.

Organizational Design

Support an eyes-open acquisition process that takes future integration into consideration from the start.

Acquisition Support

Develop or refine clinical processes to ensure compliance with national and global regulatory requirements.

Compliance

Provide coaching and guidance to executives inheriting new responsibilities,
supporting them through the critical first six months of their new role.

Leadership Support

Anchor 2

Our Services

We work with a range of organizations from emerging to global.

Develop or refine clinical processes to ensure compliance with national and global regulatory requirements.

Clinical Operational Compliance

Projects:

Process Development
Standard Operating Procedure / Procedural Document Creation
Training Development
White-Glove Rollout Service

Projects:

Process Development
Standard Operating Procedure / Procedural Document Creation
Training Development
White-Glove Rollout Service

Deliver business results measurably faster and with less effort through process optimization.

Projects:

Gap Analysis
Process Development
Standard Operating Procedure / Procedural Document Creation
Training Development
White-Glove Rollout Service

Process Efficiency in Clinical Operations

Define the minimum viable information system environment and/or determine if the benefits of potential information systems justify the costs.

Projects:

Systems Strategy
Systems Value Proposition

System Strategy

Conduct a value-driven system selection, support the configuration of the selected system and support the rollout of the system to ensure the expected benefit is achieved.

Projects:

Systems Value Proposition
Requirements Definition
Systems Selection
Program Management
Configuration Leadership
Training Development
White-Glove Rollout Service

System Selection and Implementation

Develop organization evolution plans, setting out a roadmap for taking an
organization from its current state to its required future state.

Projects:

Gap Analysis
Organization Evolution Roadmap
Position Description Development
Staff Evaluation and Placement

Organization Strategy

Provide coaching and guidance to executives inheriting new responsibilities supporting them through the critical first six months of their new role.

Projects:

Leadership Support
Gap Analysis

Leadership Support

Evaluate the opportunity the client is interested in investing in and provide
strategic recommendations, risk analysis and integration planning.

Projects:

Acquisition Value Proposition
Due Diligence
Pipeline Analysis
Integration Planning

Acquisition Due Diligence

Drive the integration of an acquisition to realize the expected benefits as quickly as possible.

Acquisition Integration Leadership

Projects:

Integration Planning
Program Management
Gap Analysis
Process Development
Standard Operating Procedure / Procedural Document Creation
Training Development
White-Glove Rollout Service

People Initiatives

Organizing structure design and staffing levels
Role, Responsibilities, RACI and Position Description Development
Outsourcing Process, Vendor Selection and Management
Culture Change through Leadership Coaching and Education
Metrics and Incentives Implementation

Process Initiatives

Process Optimization and Process Redesign
Process Documentation, including Work Flows, SOPs and Guidance Documents
Process Quality Assurance
Process Management Systems

Technology

Initiatives

Technology Requirements Definition
Technology System Evaluation and Selection
Technology Remediation and Improvement Programs
Implementation Planning and Management
Failing Implementation Rescue

Define the minimum viable information system environment and/or determine if the benefits of potential information systems justify the costs.

Projects:

Systems Strategy
Systems Value Proposition

System Strategy

Provide coaching and guidance to executives inheriting new responsibilities supporting them through the critical first six months of their new role.

Leadership Support

Projects:

Leadership Support
Gap Analysis

Conduct a value-driven system selection, support the configuration of the selected system and support the rollout of the system to ensure the expected benefit is achieved.

System Selection and Implementation

Projects:

Systems Value Proposition
Requirements Definition
Systems Selection
Program Management
Configuration Leadership
Training Development
White-Glove Rollout Service

Drive the integration of an acquisition to realize the expected benefits as quickly as possible.

Integration Leadership

Projects:

Program Management
Gap Analysis
Process Development
Standard Operating Procedure / Procedural Document Creation
Training Development
White-Glove Rollout Service

Develop efficient, compliant Medical Affairs process.

Medical Affairs Process Optimization

Projects:

Gap Analysis
Process Development
Standard Operating Procedure / Procedural Document Creation
Training Development
White-Glove Rollout Service

Advise and develop approaches for Medical Affairs that help them achieve their goals while remaining compliant to both US and Global regulations.

Medical Affairs Compliance

Projects:

Gap Analysis
Process Development
Standard Operating Procedure / Procedural Document Creation
Training Development
White-Glove Rollout Service

Create a roadmap for the development of a new or enhanced medical affairs organization, including establishing the relationship between Medical Affairs and other functions.

Medical Affairs Organization Strategy

Projects:

Medical Affairs Strategy
Medical Affairs Roadmap

Create an in-depth medical affairs launch plan, including expected staffing, infrastructure needs and deliverables.

Medical Affairs Launch Planning

Projects:

Medical Affairs Strategy
Medical Affairs Launch Plan

People Initiatives

Organizing structure design and staffing levels
Role, Responsibilities, RACI and Position Description Development
Outsourcing Process, Vendor Selection and Management
Culture Change through Leadership Coaching and Education
Metrics and Incentives Implementation

Process Initiatives

Process Optimization and Process Redesign
Process Documentation, including Work Flows, SOPs and Guidance Documents
Process Quality Assurance
Process Management Systems

Technology

Initiatives

Technology Requirements Definition
Technology System Evaluation and Selection
Technology Remediation and Improvement Programs
Implementation Planning and Management
Failing Implementation Rescue

Develop or refine clinical processes to ensure compliance with national and global regulatory requirements.

Clinical Operational Compliance

Projects:

Process Development
Standard Operating Procedure / Procedural Document Creation
Training Development
White-Glove Rollout Service

Projects:

Process Development
Standard Operating Procedure / Procedural Document Creation
Training Development
White-Glove Rollout Service

Deliver business results measurably faster and with less effort through process optimization.

Projects:

Gap Analysis
Process Development
Standard Operating Procedure / Procedural Document Creation
Training Development
White-Glove Rollout Service

Process Efficiency in Clinical Operations

Define the minimum viable information system environment and/or determine if the benefits of potential information systems justify the costs.

Projects:

Systems Strategy
Systems Value Proposition

System Strategy

Conduct a value-driven system selection, support the configuration of the selected system and support the rollout of the system to ensure the expected benefit is achieved.

System Selection and Implementation

Projects:

Systems Value Proposition
Requirements Definition
Systems Selection
Program Management
Configuration Leadership
Training Development
White-Glove Rollout Service

Develop organization evolution plans, setting out a roadmap for taking an
organization from its current state to its required future state.

Organization Strategy

Projects:

Gap Analysis
Organization Evolution Roadmap
Position Description Development
Staff Evaluation and Placement

Provide coaching and guidance to executives inheriting new responsibilities supporting them through the critical first six months of their new role.

Leadership Support

Projects:

Leadership Support
Gap Analysis

Evaluate the opportunity the client is interested in investing in and provide
strategic recommendations, risk analysis and integration planning.

Projects:

Acquisition Value Proposition
Due Diligence
Pipeline Analysis
Integration Planning

Acquisition Due Diligence

Drive the integration of an acquisition to realize the expected benefits as quickly as possible.

Acquisition Integration Leadership

Projects:

Integration Planning
Program Management
Gap Analysis
Process Development
Standard Operating Procedure / Procedural Document Creation
Training Development
White-Glove Rollout Service

Develop efficient, compliant Medical Affairs process.

Medical Affairs Process Optimization

Projects:

Gap Analysis
Process Development
Standard Operating Procedure / Procedural Document Creation
Training Development
White-Glove Rollout Service

Advise and develop approaches for Medical Affairs that help them achieve their goals while remaining compliant to both US and Global regulations.

Medical Affairs Compliance

Projects:

Gap Analysis
Process Development
Standard Operating Procedure / Procedural Document Creation
Training Development
White-Glove Rollout Service

Create a roadmap for the development of a new or enhanced medical affairs organization, including establishing the relationship between Medical Affairs and other functions.

Medical Affairs Organization Strategy

Projects:

Medical Affairs Strategy
Medical Affairs Roadmap

Create an in-depth medical affairs launch plan, including expected staffing, infrastructure needs and deliverables.

Medical Affairs Launch Planning

Projects:

Medical Affairs Strategy
Medical Affairs Launch Plan

People Initiatives

Organizing structure design and staffing levels
Role, Responsibilities, RACI and Position Description Development
Outsourcing Process, Vendor Selection and Management
Culture Change through Leadership Coaching and Education
Metrics and Incentives Implementation

Process Initiatives

Process Optimization and Process Redesign
Process Documentation, including Work Flows, SOPs and Guidance Documents
Process Quality Assurance
Process Management Systems

Technology

Initiatives

Technology Requirements Definition
Technology System Evaluation and Selection
Technology Remediation and Improvement Programs
Implementation Planning and Management
Failing Implementation Rescue

Develop or refine clinical processes to ensure compliance with national and global regulatory requirements.

Clinical Operational Compliance

Projects:

Process Development
Standard Operating Procedure / Procedural Document Creation
Training Development
White-Glove Rollout Service

Projects:

Process Development
Standard Operating Procedure / Procedural Document Creation
Training Development
White-Glove Rollout Service

Deliver business results measurably faster and with less effort through process optimization.

Projects:

Gap Analysis
Process Development
Standard Operating Procedure / Procedural Document Creation
Training Development
White-Glove Rollout Service

Process Efficiency in Clinical Operations

Define the minimum viable information system environment and/or determine if the benefits of potential information systems justify the costs.

Projects:

Systems Strategy
Systems Value Proposition

System Strategy

Conduct a value-driven system selection, support the configuration of the selected system and support the rollout of the system to ensure the expected benefit is achieved.

System Selection and Implementation

Projects:

Systems Value Proposition
Requirements Definition
Systems Selection
Program Management
Configuration Leadership
Training Development
White-Glove Rollout Service

Develop organization evolution plans, setting out a roadmap for taking an
organization from its current state to its required future state.

Organization Strategy

Projects:

Gap Analysis
Organization Evolution Roadmap
Position Description Development
Staff Evaluation and Placement

Provide coaching and guidance to executives inheriting new responsibilities supporting them through the critical first six months of their new role.

Leadership Support

Projects:

Leadership Support
Gap Analysis

Drive the integration of an acquisition to realize the expected benefits as quickly as possible.

Acquisition Integration Leadership

Projects:

Integration Planning
Program Management
Gap Analysis
Process Development
Standard Operating Procedure / Procedural Document Creation
Training Development
White-Glove Rollout Service

People Initiatives

Organizing structure design and staffing levels
Role, Responsibilities, RACI and Position Description Development
Outsourcing Process, Vendor Selection and Management
Culture Change through Leadership Coaching and Education
Metrics and Incentives Implementation

Process Initiatives

Process Optimization and Process Redesign
Process Documentation, including Work Flows, SOPs and Guidance Documents
Process Quality Assurance
Process Management Systems

Technology

Initiatives

Technology Requirements Definition
Technology System Evaluation and Selection
Technology Remediation and Improvement Programs
Implementation Planning and Management
Failing Implementation Rescue

Change Management

People support what they create

AWARENESS

Acknowledgement of the gaps in capabilities needed to achieve goals by the people who need to make the changes

OWNERSHIP

Identify and engage Change Drivers who will both support the design and advocate for the adoption of changes

EMBEDDING

Roll out change from the Change Drivers to the rest of the organization through training and support

COMMUNICATIONS

Internal and stakeholder ongoing communication to engage and prepare the organization

Our Expertise

Pharma Initiatives specializes in designing, building, and optimizing clinical development and medical affairs operations.

Our Services

We work with a range of organizations from emerging to global.

Change Management

People support what they create

​

AWARENESS

​

​

​