Capabilities

Phase I
Phase I

To support your early phase studies, Pharm-Olam offers a complete suite of services to help you to create a healthier world, by supporting your unique needs. Pharm-Olam can provide the following services:

  • Data Management, Biostatistics, Clinical Monitoring & Medical Writing
  • Identification of suitably experienced Phase I units
  • Medical advisory services for protocols & investigator brochures
  • Preparation of regulatory documents for regulatory authorities
  • Medical Safety (Pharmacovigilance & Medical Monitoring) including adverse event case processing, set-up of electronic reporting systems, and set-up and representation in data safety monitoring boards/institutional review boards

Pharm-Olam is well versed in identifying suitable Phase I units to obtain feasibility data, such as patient/subject availability, as well as obtaining feedback on operational and other logistical issues. Pharm-Olam has strong working relationships with a number of Phase I units located around the globe and we are committed to developing good working relationships with all sites, whether selected by you or by Pharm-Olam. We aim to obtain the highest quality data, with adherence to good practices to get the best possible results.

"Pharm-Olam provided a predictable, high quality service that has not been matched by any other CRO we have worked with." - Senior Vice President of Clinical Development and Medical Affairs


Pharm-Olam's Experience by Phase

Pharm-Olam's Experience by Phase

Bioequivalence / Biosimilar Studies

The increasing demand for generic products has created development opportunities for pharmaceutical development companies, both large and small. Pharm-Olam has a strong history of delivering bioequivalence studies in a range of therapy areas and in a variety of countries. We therefore understand the regulatory requirements specific to bioequivalence studies and the special conditions which apply to the operational aspects of the study.

Pharm-Olam’s experienced team works closely with our clients to ensure that we implement customized solutions designed specifically to meet the requirements of the study. Our extensive global reach enables rapid patient enrollment and ensures that key timelines are met.

Compiled from our past trial experience, we’ve put together 13 Tips and Suggestions for the Design and Operational Challenges encountered in Biosimilar Clinical Development. Learn more.

 

Phase II
Phase II

With your product now showing promise, you have entered a critical stage of your therapy's future success. Pharm-Olam has assisted hundreds of organizations with their development programs through our full-service solutions across the globe. To enable you to take your product to the next stage we can provide a detailed Feasibility Study, Regulatory, Data Management, Translations, Medical Monitoring, Pharmacovigilance, Statistics, Medical Writing, QA/QC, and Drug Storage services. Pharm-Olam provides turn-key solutions to your unique requirements, which enables us to work together to create a healthier world.

"Based on the performance on our study, we have selected Pharm-Olam to perform two additional studies." - Associate Director, Clinical Outsourcing

Phase III
Phase III

Your new product is meeting its key objectives. Establishing safety and efficacy is the primary goal. Pharm-Olam can assist through monitoring safety, demonstrating effectiveness, and the evaluation of benefit-risk ratio. Our complete solutions are a perfect match for your programs unique needs, and our experienced, global staff are available to support your program at any time - at any stage - starting at protocol development through final submission and post-marketing. We look forward to assisting you in your next project!

"Pharm-Olam also proved to be highly flexible, which is something I personally value and not always see at other CROs." - Director, Project Planning

Orphan Drugs
Orphan Drugs

At Pharm-Olam, the rarest studies are not rare. We have extensive experience with the most complicated indications, and we appreciate the unique challenges of managing these studies; we are able to identify and engage with specialist sites and organizations to recruit enough patients to meet your enrollment targets. To date, we have participated in over 60 orphan studies and 30 separate functional outsourcing projects. This past experience, combined with our global staff network and flat organizational structure, positions us as a perfect match for the speed and flexibility required for orphan drug approvals.

Compiled from our past trial experience, we’ve put together 11 Tips to Assist in Successful Orphan Drug Development. Learn more.

"Pharm-Olam excelled by selecting sites with dedicated, experienced investigators and the appropriate patient population, which was not a small task for a study in an orphan population such as Lupus Nephritis." - Executive Vice President, Regulatory Affairs and Clinical Operations

Phase IV / Post-Marketing
Phase IV / Post-Marketing

Late phase research is vital in ensuring the success of your product. As your experienced strategic partner, Pharm-Olam will support your needs for emerging scientific standards for design, operations, analysis, and quality assurance. Pharm-Olam will support your research objectives whether monitoring safety, demonstrating effectiveness, evaluating benefit-risk to gain market access, or proving efficacy by providing customized strategic and scientific solutions to allow you to move from product development to commercialization in a cost-effective and seamless approach.

Pharm-Olam’s late phase service offering includes:

  • Retrospective data collection
  • Health outcomes/economics
  • Effectiveness comparatives
  • REMS/safety outcomes
  • Patient-reported outcomes
  • Patient registry studies

"The Pharm-Olam contacts were very professional, supportive of our requirements, showed flexibility when necessary for the project, and have been a real pleasure to work with." - Clinical Project Manager

 

Science Driven Post-Marketing

In recent years, post-approval studies assessing real-life effectiveness, safety, patient outcomes, drug utilization, and health economics of marketed products have evolved from optional “nice to have” marketing initiatives to mandatory requirements. Governments, third party payers, patients, and health care providers rely on the results of post-marketing studies for continued reimbursement support, demonstration of effectiveness and safety. We design and execute post-marketing studies that adhere to rigorous principles of research that will generate evidence, answer valid scientific questions, and are suitable for publication.

Pharm-Olam's Post-Marketing services include:

  • Observational studies
  • Registry studies (Patient, Disease, Drug)
  • Health outcomes and economics
  • Patient reported outcomes/Quality of life
  • Phase IV studies
  • Risk-benefit and risk management evaluations
  • Post-marketing safety surveillance
Non-Interventional Clinical Trials
Non-Interventional Clinical Trials

Pharm-Olam provides a global infrastructure and local/regional expertise to support your retrospective studies with solutions in:

  • Observational database review and/or research
  • Review of records where all events have already occurred
  • Data collection from individual medical records at the site of the investigator

Pharm-Olam will evaluate usage patterns in drug utilization studies including potential off-label use, measuring the effectiveness of risk management measures, measuring effectiveness of therapeutic interventions in current practice and assist you with any project that includes health outcome assessments. Pharm-Olam also provides prospective data collection, prospective cohort studies, retrospective studies, and long-term extension studies.

Rescue Studies
Rescue Studies

Pharm-Olam has been contacted with increasing frequency when problems arise during ongoing studies. The complexity of clinical trials and the pressures of meeting deadlines can lead to the need for supplemental or replacement assistance. We are able to seamlessly work alongside other CROs using our established processes to ensure smooth integration with sponsors and/or other vendors. Our corporate structure promotes flexibility, and our working practices can be far more efficient and effective than larger organizations. At Pharm-Olam, we have worked on rescue studies in many forms, including:

  • Global project takeovers
  • Supplemental or enrollment augmentation
  • Replacing bankrupt or failing CROs
  • Re-monitoring to ensure reliable data
  • Quality Control/Assurance initiatives
  • Statistical re-analysis


Review our tips and suggestions on how to successfully manage a rescue study!


Save Time with our Experience and Proven Processes

Whether for a global project takeover or enrollment augmentation, our stand-alone or full-service solutions, global network, and local operations model has allowed many of our clients to recover lost time while maintaining their aggressive timelines. Our handover teams quickly analyze transition needs, including revised investigator agreements, monitoring, data transfer, regulatory maintenance, and enrollment. We can work in accordance with your SOPs, our own SOPs or an agreed combination.

Pharm-Olam has a Rescue Start-Up Team which quickly analyzes options for enrollment. After assessment, the transition plan is initiated by specialists in their respective areas who work in parallel to achieve regulatory approval, site agreements and logistical requirements for the study, whilst building productive relationships that focus on the ongoing success of the study.

Review a Case Study where we successfully transferred and rescued a Breast Cancer study.


Supplemental Enrollment / Enrollment Augmentation

Pharm-Olam has extensive experience in supplementing enrollment. Our global network and decentralized operations model allows us to quickly initiate sites in countries that typically have far higher rates of recruitment than the U.S. or Western Europe. Whether you need additional sites in an active country, sites in new countries, or want to hand over an ongoing study, Pharm-Olam can help you meet your enrollment needs while delivering quality data.

Health Outcomes Research
Health Outcomes Research

Knowing the Value of Your Product

Our seasoned experts can identify and deliver reliable health-outcomes research evidence. We organize and format your product's data clearly for each of your audiences (payers, regulatory authorities, physicians, and other key groups) while maintaining the scientific integrity of the source data.

We can provide submission-ready dossiers that convey the value of your product according to FDA, EMA, and other regulatory authority guidelines. Our experts can guide you in the selection and analyses of economic and health-related quality-of-life endpoints for studies across all therapeutic areas. We can assist in revealing credible information about the competitiveness of your product to help you with pricing decisions and reimbursement.

We utilize novel research methodologies to enhance the quality of our analyses and reports. We provide quality-assured deliverables whether you require strategy documents, economic regulatory dossiers, literature reviews, or reports for peer-reviewed journals.

"I hold my experiences with Pharm-Olam as examples of how a highly successful CRO should operate." - Chief Medical Officer

Compassionate Use
Compassionate Use

Pharm-Olam provides a global infrastructure and local/regional expertise to support your compassionate, expanded, extended or earlier access programs.

Pharm-Olam offers the following services to support your development program:

  • Risk assessment to support your trial design and clinical trial agreement
  • Protocol writing
  • Global/regional regulatory services
  • Monitoring
  • Data management
  • Logistics and supply chain management
  • Distribution
  • Storage
Biosimilars
Biosimilars

Fueled by the promise of reductions in the cost of treatments, interest in Biosimilar drug development has increased dramatically, particularly with recent Biosimilar drug approvals by the EMA and FDA. To move a program forward successfully, several critical questions have to be answered including: a complete analysis of biosimilarity (how similar is “similar”), extrapolation, ‘switchability’ and immunogenicity.

Pharm-Olam offers a complete solution for the development of Biosimilars, from assistance with study design to expertly managing the operational aspects of these trials.

Compiled from our past trial experience, we’ve put together 13 Tips and Suggestions for the Design and Operational Challenges encountered in Biosimilar Clinical Development. Learn more.

To learn more about our full-service solutions, contact us today!