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Our Expertise

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

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

Change Management

People support what they create

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AWARENESS

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

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OWNERSHIP

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

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EMBEDDING

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

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COMMUNICATIONS

Internal and stakeholder ongoing communication to engage and prepare the organization​

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