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ONCOLOGY CRO Services

COMPREHENSIVE CANCER RESEARCH SOLUTIONS, LED BY A DEDICATED ONCOLOGY RESEARCH TEAM AND GLOBAL NETWORK OF ONCOLOGISTS. 
A Center of Excellence

SPECIALISTS IN CANCER RESEARCH

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Number of Studies:
91

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Number of Patients:
8,721

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Number of Sites:
1,612

Supporting Oncology research in Phases I-IV is one of our key pillar's in Pharm-Olam’s research foundation, and is considered a Center of Excellence due to the dedicated staff, technology, partnerships and investments being made by Pharm-Olam to support our Sponsors.  From Regulatory to Project Management, and from Medical Monitoring to Data Management, our cross-functional, integrated solutions ensure compliance, data accuracy, and timely while improving cost efficiency through our Earned Value Management (EVM) model.

In addition, Pharm-Olam is often asked to perform rescue CRO services (augment or replace existing CRO service provider) for oncology clinical trials. Our ability to help clients achieve their original recruitment or enrollment goals frequently leads to Pharm-Olam being chosen for additional responsibilities, including Pharmacovigilance and Quality Assurance. Regardless of how we are engaged, Pharm-Olam is committed to your long-term success.

We have conducted CRO services across a broad range of oncology indications and treatment modalities, including:

  • Breast
  • Cervical
  • Colorectal
  • Esophageal
  • Gastric
  • Glioblastoma
  • Head and Neck
  • Hepatocellular
  • Immuno-oncology
  • Leukemia
  • Lymphoma
  • Myelofibrosis
  • Myeloma
  • NSCLC
  • Ovarian
  • Pancreatic
  • Prostate
  • Renal Cell
  • Supportive Care
  • Testicular
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Study Design & Consultation Services

Pharm-Olam offers sponsors and investigators the opportunity to discuss and formulate their research question about the design, conduct or analysis of data for their clinical trial.

We offer:

  • Creating clinical development plan
  • Clinical trial design consulting
  • Guidance on protocol development
  • Advice on framing endpoints for oncology clinical trials
  • Integrating outcome endpoints like PK PD correlation, tumor volume vs bi-dimensional response, AE vs response correlation, etc.
  • Strategies for data monitoring
  • Consultation on meeting regulatory requirements for clinical trials
  • Biostatistics and Data Management consultation is also available from our integrated teams
  • Consultation on Quality Assurance
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IND Support & Submissions

Pharm-Olam offers full IND and Pre-IND support services for sponsors of all sizes   and at all stages of their oncology research project.

Our Center of Excellence provides guidance and consulting, including:

  • Answering questions about the submission process
  • Assisting sponsors in complying with the regulatory requirements
  • Ensuring that investigators obtain the appropriate data needed for successful submissions
  • Assisting with collecting and compiling documents, and submitting applications to the FDA and EMA
  • Developing data and safety monitoring plans
  • Assisting with the renewal of applications
  • Writing and submitting progress reports

This results in a reduced administrative burden on investigators because Pharm-Olam maintains, manages, and monitors INDs, including those involving external sites.

Oncology pediatric trials
Global Network of Research-Focused Oncologists

Pharm-Olam offers your oncology trial:

  • Expedited site start-ups and activations due to established relationships in more than 60 countries
  • Leveraging relationships with global and local site networks
  • Access to Key Opinion Leaders (KOLs) and to Pharm-Olam’s medical staff, including Dr. Dhiraj Abhyankar, our on-staff oncologist and head of the Oncology Center of Excellence
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Oncology Experienced & Trained Staff

Pharm-Olam maintains staff dedicated to Oncology research through our Center of Excellence.  We are highly experienced in managing the complexities of oncology study designs and adept at cohort and site management, coordination thereof.

About Pharm-Olam's dedicated Oncology team:

  • >80% of our PMs have oncology clinical research experience
  • >75% of our CRAs have oncology clinical research experience
  • Ensures consistency in project management due to our better-than-average retention rate amongst project staff
Oncology pediatric trials
Specializing in Pediatric Trials

Childhood cancer is an increasingly important subset of oncology research. With less than 4% of all federal funding going to pediatric cancer research, sponsors are boldly furthering research on their own.

Pediatric trials often face a complex set of criteria and considerations, including informed consent, study endpoint definition, patient recruitment and access to patients over a designated amount of time.

Pharm-Olam’s pediatric specialty services are born of over two decades of progressive, complex research study experience. Our physicians and regulatory experts are able to provide advice specific for the conduct of studies in this unique and vulnerable population.

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