Embedded Solutions

Connecting clients with a flexible hiring alternative at the asset and clinical trial levels.

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Flexible Alternative to Hiring

Bringing a new drug to market is a complex and challenging process that requires specialized scientific and project management expertise. From the initial study documents (e.g., IND, CTA, etc.) to the final submission documents (e.g., NDA, MAA, etc.), ProPharma has successfully helped over one thousand clients by providing advice, guidance, and scientific or project management support required to navigate the drug development process.

All Embedded Solutions

ProPharma’s Embedded Solutions group helps our clients at both the asset and clinical trial levels by focusing on strategic, high-level consulting opportunities, and implementing those solutions.

embedded solutions

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We understand the importance of time in the early development process. Embedded Solutions provides a flexible alternative to traditional hiring. ProPharma provides “just-in-time” consultants to ensure our clients can avoid multi-month lead times that typically accompany the hiring of an internal employee. We also help our clients minimize the long-term costs related to hiring full-time internal employees. ProPharma collaborates closely with our clients to understand their needs. This enables us to quickly engage and place the right consultant embedded directly into your client environment. Our goal is to deliver successful results efficiently and effectively. 

Asset Level

At the asset level, ProPharma helps our clients in three main areas:

Development Plans

ProPharma serves as a trusted partner for both Scientific and Program Management needs. We work closely with our clients to understand their specific requirements and deploy the necessary team of Scientific and Program Management experts needed to provide the services required. Our consulting services range from adjusting existing development plans to creating new plans based on specific client needs.

Our Drug Development Program Managers provide essential services to the drug development programs. Their expertise includes cross-functional planning, timeline management, resource management, cost management, issue management, and risk mitigation among others.

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Furthermore, our Embedded Solutions consultants offer the option of individual subject matter experts or a team of experts embedded within the client’s environment. A typical team might include the following consultants:

  • Program Management
  • Regulatory Strategy
  • CMC
  • Nonclinical
  • Clinical Design
  • Any other areas for program support

This team of experts will assist in answering questions, preparing board meetings, help you prepare for funding discussions, etc. We are your trusted partner for scientific and program management experts.

Program Management

Depending on client needs, there are scenarios in which a Program Manager is needed who can seamlessly integrate with your existing team. This positions them to effectively lead the development teams and navigate the complexities of the drug development process. Whether you have an early-stage asset or late-stage asset, we can provide the appropriate experts to meet your development needs.

We specialize in providing an array of professional consultants including:

  • Drug Development Program Managers
  • Regulatory Program Managers
  • CMC Program Managers
  • Clinical Project Managers
  • Among others

Our Program Managers’ expertise spans a wide range of therapeutic areas including cell and gene therapy, immuno-oncology, rare disease, CNS, and CRISPR, among many others. Our consultants are true experts within their respective fields, equipped to handle any challenge that may arise.

Scientific Experts

Embedded Solutions provides specialized scientific experts who can seamlessly integrate into your client teams, leveraging their experience, existing skill sets, and industry knowledge. This enables quick collaboration and promotes cohesiveness, leading to the efficient progression of the asset through the drug development process.

Our experts excel in identifying risks to the Development Plan and implementing appropriate measures to address them effectively. We can deploy:

  • Nonclinical Consultants
  • Bioanalytical Consultants
  • Toxicology Consultants
  • CMC Consultants
  • Among others
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Clinical Trial Level

At the clinical trial level, our services Offer the necessary flexibility to meet our clients’ specific needs. We specialize in various areas including:

  • Clinical Operations
  • Data Management
  • Biostatistics & Programming
  • Medical Writing
  • Clinical/Medical Oversight

ProPharma's Embedded Solutions team actively engages in high-level strategic consulting opportunities tailored to our clients' requirements. By deploying expert consultants, we provide an alternative to hiring full-time internal team members. This approach ensures immediate results without the constraints associated with hiring internal employees.

Embedded Solutions for All Stages

Choose Embedded Solutions for flexible alternatives to traditional hiring. With our "just-in-time" consultants, you can avoid long lead times and minimize long-term costs associated with hiring full-time employees.  Our dedicated team will work to understand your specific needs and promptly place the perfect consultant directly into your client environment. Take the first step today by reaching out to us!

News & Insights

Why Medical Information Is Critical to Adverse Event Reporting

June 1, 2026

Why Medical Information Is Critical to Adverse Event Reporting

Discover the vital role of Medical Information in adverse event reporting and how it enhances patient safety and regulatory compliance in the pharmaceutical industry.

Rethinking the Role of the Medical Information Contact Center: An Untapped Resource for Medical Writing

May 25, 2026

Rethinking the Role of the Medical Information Contact Center: An Untapped Resou...

Explore how Medical Information contact centers can enhance medical writing by leveraging their expertise and adaptability in response to evolving demands.

Rethinking Biometrics Resourcing in Modern Clinical Trials

May 19, 2026

Rethinking Biometrics Resourcing in Modern Clinical Trials

Explore how the Biometrics Functional Service Provider model transforms clinical trials, enhancing data integrity, speed, and long-term performance in a complex landscape.

ProPharma Appoints Adrian Pencak as Chief Commercial Officer

May 27, 2026

ProPharma Appoints Adrian Pencak as Chief Commercial Officer

ProPharma announces Adrian Pencak as Chief Commercial Officer, bringing 25 years of leadership experience to enhance global commercial capabilities and client partnerships.

ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero Targets

January 27, 2026

ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero T...

ProPharma’s greenhouse gas reduction targets are validated by SBTi, aligning with the Net-Zero Standard and a commitment to reach net-zero by 2050.

ProPharma Expands Operations with New Office in Hyderabad

December 11, 2025

ProPharma Expands Operations with New Office in Hyderabad

ProPharma expands with a new office in Hyderabad, enhancing innovation and growth in regulatory, clinical, and compliance services for the life sciences industry.

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Case Study Keeping Research Moving Under Pressure: Delivering Data Integrity at Speed

May 20, 2026

Keeping Research Moving Under Pressure: Delivering Data Integrity at Speed - Pro...

When patient enrollment rapidly exceeds expectations, clinical trials can face significant operational strain, putting data integrity, timelines, and critical sponsor decisions at risk. A mid-size...

Case Study Reestablishing FDA Alignment After a CMC Disruption: A Strategic Path to BLA Approval

May 20, 2026

From Clinical Hold to Approval: Overcoming CMC Challenges to Achieve BLA Approva...

A critical CMC change during Phase 3 development led to a partial clinical hold, putting timelines, regulatory alignment, and commercial readiness at risk. In this case study, learn how we partnered...

Case Study Response to Regulatory Request with Subsequent Full Signal Assessment

May 15, 2026

Response to Regulatory Request with Subsequent Full Signal Assessment - ProPharm...

Responding to urgent regulatory safety requests requires balancing speed, scientific rigor, and global compliance. When concerns emerged regarding a potential neurotoxicity signal, the client needed...

Foundations of a Compliant EU–UK GMP–GDP Supply Chain: From Importation to Distribution

June 2, 2026

Foundations of a Compliant EU–UK GMP–GDP Supply Chain: From Importation to Distribution

A compliant and efficient EU–UK GMP–GDP supply chain requires a clear understanding of roles, responsibilities, and operational integration across importation, certification, and distribution...

Clinical Promise to Commercial Reality: The Path to Cell & Gene Therapy Market

April 23, 2026

Clinical Promise to Commercial Reality: The Path to Cell & Gene Therapy Market

As cell and gene therapies transition from clinical development to commercialization, organizations face evolving regulatory expectations, expanded CMC requirements, and increased MAH...

EMA Policy 0070: Advanced Strategies for Compliance, Anonymization, and CCI Justification

April 9, 2026

EMA Policy 0070: Advanced Strategies for Compliance, Anonymization, and CCI Justification

As European Medicines Agency Policy 0070 enters its expanded Step 2 phase, sponsors face increased document volumes, heightened transparency obligations, and greater scrutiny of anonymization and CCI...

News & Insights

Why Medical Information Is Critical to Adverse Event Reporting

June 1, 2026

Why Medical Information Is Critical to Adverse Event Reporting

Discover the vital role of Medical Information in adverse event reporting and how it enhances patient safety and regulatory compliance in the pharmaceutical industry.

Rethinking the Role of the Medical Information Contact Center: An Untapped Resource for Medical Writing

May 25, 2026

Rethinking the Role of the Medical Information Contact Center: An Untapped Resou...

Explore how Medical Information contact centers can enhance medical writing by leveraging their expertise and adaptability in response to evolving demands.

Rethinking Biometrics Resourcing in Modern Clinical Trials

May 19, 2026

Rethinking Biometrics Resourcing in Modern Clinical Trials

Explore how the Biometrics Functional Service Provider model transforms clinical trials, enhancing data integrity, speed, and long-term performance in a complex landscape.

Previous Post Arrow Next Post Arrow
ProPharma Appoints Adrian Pencak as Chief Commercial Officer

May 27, 2026

ProPharma Appoints Adrian Pencak as Chief Commercial Officer

ProPharma announces Adrian Pencak as Chief Commercial Officer, bringing 25 years of leadership experience to enhance global commercial capabilities and client partnerships.

ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero Targets

January 27, 2026

ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero T...

ProPharma’s greenhouse gas reduction targets are validated by SBTi, aligning with the Net-Zero Standard and a commitment to reach net-zero by 2050.

ProPharma Expands Operations with New Office in Hyderabad

December 11, 2025

ProPharma Expands Operations with New Office in Hyderabad

ProPharma expands with a new office in Hyderabad, enhancing innovation and growth in regulatory, clinical, and compliance services for the life sciences industry.

Previous Post Arrow Next Post Arrow
ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Previous Award Arrow Next Award Arrow
Case Study Keeping Research Moving Under Pressure: Delivering Data Integrity at Speed

May 20, 2026

Keeping Research Moving Under Pressure: Delivering Data Integrity at Speed - Pro...

When patient enrollment rapidly exceeds expectations, clinical trials can face significant operational strain, putting data integrity, timelines, and critical sponsor decisions at risk. A mid-size...

Case Study Reestablishing FDA Alignment After a CMC Disruption: A Strategic Path to BLA Approval

May 20, 2026

From Clinical Hold to Approval: Overcoming CMC Challenges to Achieve BLA Approva...

A critical CMC change during Phase 3 development led to a partial clinical hold, putting timelines, regulatory alignment, and commercial readiness at risk. In this case study, learn how we partnered...

Case Study Response to Regulatory Request with Subsequent Full Signal Assessment

May 15, 2026

Response to Regulatory Request with Subsequent Full Signal Assessment - ProPharm...

Responding to urgent regulatory safety requests requires balancing speed, scientific rigor, and global compliance. When concerns emerged regarding a potential neurotoxicity signal, the client needed...

Previous Resource Arrow Next Resource Arrow
Foundations of a Compliant EU–UK GMP–GDP Supply Chain: From Importation to Distribution

June 2, 2026

Foundations of a Compliant EU–UK GMP–GDP Supply Chain: From Importation to Distribution

A compliant and efficient EU–UK GMP–GDP supply chain requires a clear understanding of roles, responsibilities, and operational integration across importation, certification, and distribution...

Clinical Promise to Commercial Reality: The Path to Cell & Gene Therapy Market

April 23, 2026

Clinical Promise to Commercial Reality: The Path to Cell & Gene Therapy Market

As cell and gene therapies transition from clinical development to commercialization, organizations face evolving regulatory expectations, expanded CMC requirements, and increased MAH...

EMA Policy 0070: Advanced Strategies for Compliance, Anonymization, and CCI Justification

April 9, 2026

EMA Policy 0070: Advanced Strategies for Compliance, Anonymization, and CCI Justification

As European Medicines Agency Policy 0070 enters its expanded Step 2 phase, sponsors face increased document volumes, heightened transparency obligations, and greater scrutiny of anonymization and CCI...

Previous Webinar Arrow Next Webinar Arrow