
PRODUCTS AND SERVICES
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As a top Clinical Research Organization, ProPharma brings over 20 years of experience, innovation, personalization, and adaptability to Sponsors’ studies and research.
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Australia is a preferred destination for early phase trials because of simple and fast regulatory stream and lucrative R&D cash refund scheme.
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At ProPharma, our Cell and Gene Therapy consulting team offers a comprehensive and integrated approach to early-stage cell and gene therapy development. Our expert team provides a range of services, including IND/CTA preparation, manufacturing technology, safety and risk assessment, and development planning, to help our clients navigate the complex and ever-changing landscape of cell and gene therapy development.
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The full-service Contract Research Organization (CRO) with operations in Australia, New Zealand, Asia, North America, and Europe.
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A global team of trusted experts for multi-phase clinical development.
WHITE PAPERS AND CASE STUDIES
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Phase IIb Trial: Evaluating A Novel Treatment For Locally Advanced Or Metastatic Breast Cancer
This case study highlights a successful Phase IIb clinical trial conducted by an Indian biotech company evaluating a novel treatment for Locally Advanced or Metastatic Breast Cancer.
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How To Recruit 236 Patients In An Osteoarthritis Study On Time During The Peak Of The Pandemic
A leading Eastern European contract research organization completed the recruitment of 236 subjects in a Phase 3 osteoarthritis study for Handok Inc. despite hurdles caused by the COVID-19 pandemic.
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Patient Diversity: Identifying Challenges, Opportunities, And Best Practices
By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.
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Expert Consulting And MRCT Strategy Rescues Oncology Program
Uncover how this strategic approach yielded significant outcomes, including uncovering missing data through IB review, streamlining dosing timelines, and achieving successful recruitment milestones.
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Advancing From Single Country Phase 1 Success To Multinational Phase 1/2 Trial
Explore how this partnership aims to contribute to the success of the trial by leveraging global resources and streamlining processes for efficient and timely results.
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A Comprehensive Planning Approach For Cancer Antibody
Discover how a clinical-stage biotech company was able to accelerate pathways for development and regulatory review of their first Phase 1 protocol for an immuno-oncology antibody.
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Spotlight On India: Regulatory Enhancements, Modernization, And Robust Data Collection
Explore India's adoption of global best practices, 24/7 work cycles, and audit readiness to ensure high standards of Good Clinical Practice, attract more trials, and provide robust data to stakeholders.
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Providing Packing And Blinding Solutions For An Innovative Drug Start-Up
Discover how a CDMO with integrated services enabled a botanical drug start-up to commence its Phase 1 clinical trial, paving the way for further advancement of its innovative botanical drug.
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Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer
Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency, reliability, and innovation in bioprocessing workflows.
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Boosting CMC Regulatory Efficiency In Gene Therapy
Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.
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Transforming Clinical Trial Sites With Research Study Rockstar
This innovative platform addresses prevalent pain points faced by trial coordinators by streamlining workflows, automating patient communication, and providing intuitive dashboards that simplify trial management.
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Using IRT Data To Automate And Optimize Clinical Supply
Learn how clinical teams can save between $150,000 and $1 million in annual drug and shipping costs through automated supply optimization.
NEWS
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CTI Announces Additional College Of American Pathologists (CAP) Laboratory Accreditation2/21/2024
CTI Clinical Trials and Consulting, a full-service global research provider, is thrilled to announce that our North American laboratory facility has been granted the prestigious College of American Pathologists (CAP) Accreditation for Safety Testing.
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EPNextS Group And Frontage Laboratories, Inc. Announce Collaboration In Early Phase Clinical Trials In The United States To Improve 'Drug Lag' And 'Drug Loss' Issues In Japan3/26/2024
EPNextS Group, a Japanese based leading provider of clinical trial solutions, and Frontage Laboratories, Inc., a US based full-service contract research organization (CRO), have announced a collaboration aimed at addressing the challenges of "Drug Lag" and "Drug Loss" in Japan.
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Thermo Fisher Scientific Expands Clinical Research Laboratory In Wisconsin6/18/2024
The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, today unveiled a new clinical research laboratory building at its good manufacturing practices (GMP) lab in Middleton, Wisconsin.
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Oracle Advances Global RTSM Capabilities To Help Sponsors5/13/2024
Latest updates to Oracle Clinical One RTSM cloud-based solution make it easier for sponsors and CROs to configure, scale, and automate to support complex and global clinical trial studies
ABOUT
Clinical trials
Clinical trials refer to any research done in any medical field. The main objective of clinical research is to find solutions to better screening, preventing, diagnosis and treatment of diseases. Trends such as clinical trial globalization have been credited for the increased dominance of these trials in the medical field. Pharmaceutical companies have stepped a notch higher by not limiting their trials to their native countries. North American companies have moved to Asia and Eastern Europe since these areas offer lower costs and higher patient numbers.
Globalization comes with its own challenges since one has to conform to the regulatory standards set by the individual regulators in the new areas they venture into. The research infrastructure in some of these areas is not up to a similar scale to that in the areas a manufacturer operates in. Intellectual property ownership and biospecimen ownership might be issues that can lead to delay in commencement. These complications along with ethical issues might be limiting factors.
Clinical trials usually occur in three phases. The first phase involves human testing. This is important in establishing the amount required as dosage. The second phase involves accessing if the administration has an effect in relation to what is being tested. For instance, the second phase in cancer trials determines the anti-cancer effects of an administration. The last phase involves comparing the patients using a tested treatment with those in the standardized treatments.
Though some people are still skeptical about clinical trials due to the uncertainty, there are numerous others who are willing to participate in these trials. The principle investigators and their team are responsible for ascertaining the safety and the risks involved in a trial. One needs not to be worried since these professionals have credentials that will be applied in ensuring safety of all the participants.