Case Studies

 

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Monitoring in the Field

A large west coast specialty pharmaceutical company needed a monitoring solution that would be cost and time-effective for three Phase II study programs.

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When a Team Loses Their Leader Without a Plan

A pharmaceutical client had a global project team that included representatives from Development, Safety, Pharmacovigilance, and IT. Their project was to implement an online portal for the delivery of Safety Letters to Investigators.

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Transfer & Manage Clinical Data Provided by Multiple Third-Party Vendors

Challenged by tight database go-live timelines, complex non-CDISC third-party smartphone application data, and large volumes of continuously collected records per subject.

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Planet Pharma provides expert staffing support for an Immuno-Oncology Biotech

The client is a clinical-stage immuno-oncology biotech company based in Belgium. They are committed to developing novel and innovative treatments to improve the clinical benefits of oncology therapies.

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When a Team Lacks Industry Experience

The challenge was to unite a global project team from three organizations and provide experienced leadership in CSV and SQA to bridge communication gaps, align technical requirements, and drive the project to meet critical milestones.

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Staffing Solution for Life Sciences Company Expanding European Operations

The client is a leading global provider of software as a service (SaaS) solutions for Life Science corporations. They enable companies in Pharmaceuticals, Diagnostics, Biotech, Medical Devices and other segments to track, capture, and analyze clinical data on their software platform.

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Managing Complex Pharma Projects

Our pharmaceutical client needed a technically skilled Project Manager with diagnostic business expertise to provide clear leadership and align a global, multi-company team that was struggling with too many decision-makers and missed deadlines.

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Laboratory Informatics with Robotics

Managing the complex workflow between ELN, LIMS, SDMS, instruments, and robotics requires careful coordination of scientific processes while aligning scientists with business needs and technology limitations.

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COVID-19 PCR Lab Facility: Staffing & Management Solution

Partnering with a pharmaceutical organization on a COVID-19 medical study, the client needed a scalable team to manage high volumes of drug safety case reports, requiring rapid recruitment of medical personnel to support case intake, data management, and review.

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Clinical Stage Immuno-Oncology Contract & Direct Hire Staffing

A clinical-stage immuno-oncology biotech company in Belgium needed experienced talent to support their transition from Phase II to Phase III but faced challenges sourcing qualified professionals quickly, prompting them to partner with a specialized recruiter to secure the regional expertise required to keep development on track.

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Medical Device Manufacturer Remediation

After receiving a Form 483 and Warning Letter for deficiencies in aseptic manufacturing, validation, and quality systems, a global medical device manufacturer partnered with Planet Pharma to quickly hire experts to conduct a risk-based CAPA review within two months and provide leadership to support critical quality improvement initiatives.

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Custom PMO Design & Implementation

A Top 25 pharmaceutical company struggling with an over-committed portfolio, limited management visibility, and inconsistent project management practices turned to Planet Pharma to provide the leadership and support needed to streamline processes, increase transparency, and reduce project start-up times.

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Head of Translational Medicine

The client is a Drug discovery company developing therapies for neurodegenerative diseases by integrating human genomics with AI/ML; TA focus of ALS and Parkinson’s disease.

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Senior Vice President, Global Development Operations

A clinical stage biotechnology company located in San Francisco, California with a TA focus in Neurodegenerative and autoimmune disorders.

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EU MDR PMO & Project Delivery

Medical Devices client had the right level of internal talent but was overloaded with daily work and EU MDR (2017/745) expectations.

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Launching a Multi-Million Dollar Project On Time

A Top 25 Pharmaceutical organization planned to implement a large, enterprise technology solution with a project team located around the world.

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NDA Medical Writing

A Midwest-based pharmaceutical client needed medical writing and biometric support for a 505(b)(2) New Drug Application (NDA).

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Program Integration

An international facilities services firm with more than 500,000 global employees was chosen to manage all facilities services for a global pharmaceutical client.

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Clinical Monitoring Change Management

Planet Pharma staffed talent to support the implementation of a customized solution at a Top 25 Global Pharmaceutical Organization.

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Data Integrity

Our client, an international manufacturer of parenteral drug solutions, found inconsistencies in their laboratory data suggestive of manipulation.

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Chief Medical Officer, Confidential Search

The client is a Series A immunotherapy biotechnology company developing novel T cell therapies including chimeric antigen receptor (CAR) and engineered T cell receptor (TCR) therapies.

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Statistical Analytics with Machine Learning Tool Enablement

The client, new to the industry with minimal technical experience, faced significant process complexities, limited vendor support, and challenges using a complex tool within a multi-tenant system dependent on other platforms.

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Vice President, Biometrics

The client is a Publicly held, Seattle-based biotechnology company focused on developing biologics for Oncology, Autoimmune, and Inflammatory diseases.

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Two Directors of Discovery Biology

A NASDAQ biotechnology company located in San Francisco, CA specializing in protein degradation therapeutics in Immuno-Oncology and solid tumors.

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Senior Vice President, Clinical Development

This client is a Innovative Prescription Digital Therapeutics (PDT) company with a focus in behavioral therapy to treat conditions including Type 2 Diabetes.

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Executive Director, Discovery Pharmacology

A NASDAQ biotechnology company located in San Francisco, CA specializing in protein degradation therapeutics in Immuno-Oncology and solid tumors.

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COVID-19 Drug Safety Staffing & Management Solution

A top 10 full-service Clinical Research Organization (CRO), this client provides services to pharmaceutical, biotechnological, and medical device companies globally.

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