188 global investigators evaluate efficacy, coverage and opportunity for biologics and biosimilars in clinical development.
To learn how the feasibility process can set up future success in your clinical trial, review our infographic.
The prevalence of fast-track approvals, marketing exclusivity, tax credits and research subsidies has put the spotlight on orphan drug clinical trials. Detailed planning and timely execution of these trials are critical to the ultimate success of the product. These tips for successful orphan drug development have been collected from our work in ongoing and completed orphan drug trials.
While Belgium might not be at the top of your mind as a leading destination for clinical trials, our research shows that it is the #1 location in Europe for research activity. To learn more about the benefits Belgium has to offer, view the infographic, or get more detailed information in our Country Close-Up.
Based on the experience of our internal team, we have created a series of 13 study design and operational tips for your use.
Revised regulations in India warrant a fresh look as a viable country to run clinical trials. See why in our whitepaper.
Canada can be a viable venue for your next study. See why in our whitepaper.
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For more than 20 years, in 15 therapeutic areas across 40 countries worldwide. This is Pharm-Olam.
Ukraine is a viable and proven market for clinical research. See how it could be the next site for your trial in our whitepaper.
To see how Turkey could be a perfect fit for your trial, read our whitepaper.
To see all that Latin America has to offer sponsors, read our new whitepaper here.
For more about conducting clinical trials in Belarus, read our comprehensive whitepaper here.
During the planning of a Phase III Systemic Lupus Erythematosus (SLE) anti-B cell therapy, the Sponsor company called on Pharm-Olam to assist in the identification and enrollment of patients.
Watch the video to learn more about our full service Anti-Infective clinical trial capabilities.
Selected as a 37th Annual Telly Award winner!
At Pharm-Olam, we’re here to help. Our experienced global staff has extensive experience in the processing and management of allergy clinical trials.
See a recording of our webinar!
Rescue Studies come in many forms — from assistance in patient recruitment to a complete takeover. We know how difficult it is to think of asking for clinical trial assistance, but Pharm-Olam has been contacted with increasing frequency to support ongoing studies. During this web seminar, we discussed our experience in over 75 rescue/supplementation studies and offered lessons learned and some tips we’ve gathered along the way.
Antibiotic drug development is constantly changing and evolving with each new breakthrough driven by the urgency for new treatments. The scientific approaches used in development, along with the primary and secondary endpoints being used in research programs, are changing. This webinar will provide a high-level overview of the challenges to plan for during study design and will provide tips and suggestions on how to maximize your study’s effectiveness.
The more than 20 countries that make up Latin America offer a vast pool of diverse patients for your upcoming trials. Learn how to take advantage of the differences in demographics and stay ahead of the regulatory environment from one country to the next.
An inconsistent regulatory environment and prolonged approval process in India has forced many development companies to avoid the country as a viable destination for clinical trials.
Recent efforts by the Indian Ministry of Health and the Indian Society for Clinical Research to jointly improve the efficiency of trials in India are currently being created and implemented with the goal of improving patient safety, speed and transparency in the development process.
Thrombotic Thrombocytopenic Purpura (TTP) is a rare disease that, when left untreated leads to a 95% morbidity rate. However, 80-90% of patients that receive treatment respond favorably. In this Phase III study, Pharm-Olam International is partnering with a progressive sponsor company to assist in finding a better solution for suffering
Allergic rhinitis is a global health problem affecting between 10% and 25% of the worldwide population. In the United States, the number of allergy sufferers is over 40 million people, 25-30 million of which suffer from allergic rhinitis. In the United Kingdom, the prevelance of allergic rhinitis is 16%, Denmark is 19%, and Germany between 13% and 17%. In different regions of the Russian Federation, the prevalence of allergic rhinitis ranges from 12.7% to 24%. The condition affects both children and adults, in both sexes.
Pharm-Olam is currently partnering with a sponsor company in the development of a treatment for Glioblastoma / Anaplastic Astrocytoma. This type of brain tumor has very few available therapies, so this study’s goal is to assist in potentially identifying additional effective treatment options.
During the planning of a Phase III Systemic Lupus Erythematosus (SLE) anti-B cell therapy, the Sponsor company called on Pharm-Olam to assist in the identification and enrollment of patients.
The purpose of the study was to determine the viability of a biological agent in treating SLE patients whose disease state was severe, aggressively advancing and poorly controlled. SLE is a notoriously difficult-to-diagnose autoimmune disorder with no known cure.
In this study, Pharm-Olam was called on to rescue a Breast Cancer bioequivalence study from multiple CROs and independent contractors. Rescue studies pose many challenges and are often filled with anxiety and concern from all parties involved project.
Learn how Pharm-Olam handled the transition process to successfully support the study sponsor with aggressive patient recruitment timelines and regulatory challenges.
Pharm-Olam was contracted to provide clinical research services on a Phase I/II pediatric Respiratory Distress Syndrome study involving neonates with a gestational age between 27 and 33 weeks. This first in-human study required a single intratracheal administration within 24 to 48 hours of birth.
Discover the challenges Pharm-Olam encountered and the solutions implemented in this pediatric study.
The webinar, co-presented by ERT and Pharm-Olam, reviewed tips and suggestions on how the use of technology could maximize success when running trials in emerging regions. The webinar also includes a case study, that reviews how Pharm-Olam and ERT worked together to eliminate issues commonly encountered when operating in Emerging Regions.
To successfully manage an Acute Bacterial Skin and Skin Structure Infection (ABSSSI) study, Pharm-Olam provided a complete enrollment solution for the management and data submission of this multi-region study. With the increase of ABSSSI diagnoses and ABSSSI-related hospitalizations, inconsistent treatment methods for those diagnosed, and resistance to previous standards of care makes this an important study for those in need.
We delivered a total of 380 patients for this particular study within 9 months, which allowed for the study to be completed 2 months ahead of time.
With qualified patients becoming harder to attract into clinical trials, savvy trial managers are branching out their efforts into non-traditional countries to obtain data for their trials. This informative webinar will present detailed information about the history, process and tips on how to successfully run clinical trials in Ukraine. Further information on how to successfully run trials in Poland, Hungary, Slovakia, and Romania is also covered.
Pharm-Olam was involved as a CRO with one of the largest Systemic Lupus Erythematosus global trials, with 950 patients in over 160 sites in 20 countries. The sponsor had enrollment challenges among the 6 different CROs working on the study because the protocol required SLE patients with a history of Lupus Nephritis and other criteria.
Bioavailability and Bioequivalence (BA/BE) studies require samples of the investigational product to be retained. Typically, this is performed manually and overseen by clinical monitors during the site initiation. This manual approach is feasible for a limited number of sites. However, for studies with a large number of sites, the manual retention becomes less feasible, as it requires additional monitoring visits and the physical presence of study personnel.
In traditional manual BA/BE retention, there is no system audit trail generated, as this retention and review action occurs outside the system.
Pharm-Olam was contracted to rescue a double-blind, placebo-controlled, randomized, single ascending dose (4 levels) study, to evaluate the safety and tolerability of a biological monoclonal antibody to characterize the PK profile and to investigate the effects of the study compound on measures of disease activity in subjects with active rheumatoid arthritis. Another CRO was running the study in the UK, but after 6 months only 21 patients were randomized using 12 sites.
Ukraine has been a hot topic in the news due to the recent turmoil in the country. Even during these difficult times, drug development and clinical trials continue to be run in Ukraine, which boasts recruitment figures at least two times higher than those in the United States and Western Europe.
Pharm-Olam was contracted to provide a full-service solution for two Phase II, dose escalation allergy studies that required a total of 500 patients in Europe. With two different indications required, Grass Pollen Allergy and Birch Pollen Allergy, Pharm-Olam completed a comprehensive feasibility program and presented the findings to the sponsor for analysis and approval. Once approved,Pharm-Olam committed to recruit the required patients within 4 months, while adhering to strict inclusion and exclusion criteria.
Pharm-Olam rescued this study by recruiting 263 children (age 6-11 years) across 10 centers in Poland in two seasons. The Phase III trial assessed the efficacy and safety of oral compound tablets in pediatric subjects for treatment of seasonal allergic rhinitis. Pharm-Olam was the highest performing enroller out of several competing CROs. Data from this study was used to support successful US NDA approval for pediatric indication.
Pharm-Olam rescued this US-based study (from another CRO) that struggled to recruit 300 patients over 15 months. Pharm-Olam was able to recruit 197 patients from 12 sites in Poland in 2.5 months, allowing our sponsor to meet their enrollment target on time. The study drug later received NDA approval in pediatrics.
Pharm-Olam performed a phase III study in patients with open-angle glaucoma or ocular hypertension to assess the intraocular pressure-lowering efficacy of two compounds. We provided monitoring for all 456 patients in the study with Pharm-Olam selected sites enrolling 292 out of a target 270 patients. The study originally planned to use 43 sites, however due to fast start-up and high recruitment rates at Pharm-Olam’s sites, only 33 sites were initiated. Top recruiting countries included Hungary (121), Italy (59), and Poland (50). Pharm-Olam provided Regulatory and Ethics Submissions, Monitoring, SAE Reporting, Project Management, Training and local pharmacy arrangements.
A sponsor needed help with their strategy and implementation with a US IND for an androgen receptor antagonist for treatment of prostate cancer. Pharm-Olam’s Regulatory department provided daily consulting and preparation of the IND which was later accepted by the FDA. The sponsor was impressed with our performance and hired Pharm-Olam to run their Phase I first-in-man study where we provided Regulatory, Pharmacovigilance, Data Management, Protocol Development, Biostatistics, Monitoring and Project Management.
A sponsor conducting a large global study in 15 countries for Head and Neck cancer and had enrollment and other challenges with a CRO (a major global company) that was providing coverage in Eastern Europe. This CRO was working with 17 sites in Russia and the Ukraine which had enrolled only 21 patients after several months of recruitment. The sponsor selected Pharm-Olam to begin taking over the existing sites in Ukraine and Russia and handle regulatory submission to initiate new sites in Serbia, Croatia, and Slovakia. Pharm-Olam provided a fast, smooth transition for the existing sites and was able to achieve enrollment objectives.
The Sponsor’s hemorrhoidectomy study with another CRO was struggling with recruitment at 9 United States based sites. Pharm-Olam was asked to help with enrollment for this dose finding study with multiple cohorts and randomized 63 patients in 16 weeks (over 60% of total) with only 3 sites in Eastern Europe and less time to enroll.
To successfully complete a Phase II Post Herpetic Neuralgia (PHN) study, Pharm-Olam was contracted to provide a full-service solution to support 103 patients from 27 sites in four countries. In the past, study sponsors have had difficulty recruiting patients in Post Herpetic Neuralgia studies, but due to prior experience with these studies and a proactive approach, Pharm-Olam recruited the required number of patients seven weeks prior to the sponsors’ deadline.
Over the past 25 years, the use of Overall Survival as the primary endpoint in oncology clinical trials has steadily declined to be replaced by event free survival but response rate continues to be evaluated as primary end point specially in early phases of clinical trials.* Although OS remains the gold standard, it has been more difficult to measure due to the confounding influence of other therapies and the fact that patients are living longer, which extends the trial timeline.
Pharm-Olam provided global project management to the sponsor involving nearly 200 sites in 25 countries in a 600 patient, ICU-based, competitive recruitment study. Pharm-Olam was responsible for reviewing all regulatory packages, global medical monitoring, training and management of all vendors, which included 5 regional CROs.
Antibiotic drug development is constantly changing and evolving with each new breakthrough driven by the urgency for new treatments. This scientific approaches used in development, along with the primary and secondary endpoints being used in research programs, are changing. This ebook will provide a high-level overview of the challenges to plan for during study design and will provide tips and suggestions on how to maximize your study's effectiveness.
In the floor-and-ceiling drug resupply method, an inventory management system restocks drugs up to a site’s storage capacity, or “ceiling” level, whenever it has been depleted to protocol minimums (the “floor” level). Typically, individual unblinded drug types (e.g., active and placebo) are counted separately for the floor level, and whenever either type reaches floor level, both types are restocked to ceiling level.
Pharm-Olam International conducted two challenging studies in anemia with chronic kidney disease patients involving over 25 USA sites and 100 patients. Pharm-Olam provided Data Management, Biostatistics, Pharmacovigilance, Project Management, and Regulatory services. Pharm-Olam ensured study success by being responsive at all stages of the process and taking prompt action to keep timelines and budgets on track. The sponsor has since awarded Pharm-Olam a third study in the same indication.
For many years, India's regulatory environment, coupled with concerns about start-up timelines, data quality and ethics, has made the country a less-than-attractive option for clinical trial sponsors. However, since 2014, authorities have been hard at work revising policies in the favor of clinical research. India's evolving clinical study environment is explored in a new whitepaper.
Sponsors looking for early sites in which to launch Phase I-III trials often turn to the United States, although they can also look to Canada for similar reasons and with equal success. In fact, perhaps Canada’s greatest recommendation as a clinical trial location is that is often cited as the country most like the U.S.; sponsors familiar with operating in the U.S. will find familiar ground in Canada.
Latin America is hardly the latest new region to be discovered for conducting pharmaceutical clinical trials; global pharmaceutical companies have been running clinical trials in Latin America for over 20 years. Nonetheless, the region is noteworthy because it is still an attractive location for clinical research— and in many ways more conducive to studies than ever before.
The more than 20 countries that make up Latin America offer a vast pool of subjects for trials and patients for marketed drugs. Approximately 600 million people live in the region, which stretches from Mexico in the North to Chile and Argentina in the South. Indeed, the combined populations of just three countries, Brazil (192 million), Mexico (103 million), and Argentina (41 million), surpass the U.S. population. Sponsor companies that are sensitive to the differences in demographics and regulations from one country to the next will find that Latin America is ripe with opportunities for clinical research. The benefits—most especially easy access to a diverse patient population—outweigh the challenges of obtaining regulatory approval.
Pharm-Olam conducted a phase II study in pain treatment after open abdominal surgery with 14 sites in three Eastern European countries. The study design was randomized, double-blind, with placebo and active controls, to find optimal dose and evaluate efficacy.
Despite political unrest in a small section of the country, clinical trials are thriving in Europe’s second largest country. Large modern-treatment-naïve patient populations, expedient regulatory processes and a very low cost structure show why pharmaceutical companies have been conducting trials there for over 20 years.
Ukraine, the eighth largest European country by population, was often overlooked as a clinical trial site even before the political unrest and military actions that started in 2014. However, it remains an attractive location for those multinational companies astute enough to recognize its potential. The recent political unrest, which has been geographically confined, has closed off only about 7% of the country’s more than 575 clinical trial sites to multi-national companies (MNCs) for research studies.
This phase II study followed patients with ulcerative colitis and involved dose escalation, double-blind, and placebo aspects to test of the efficacy and safety of enema. Pharm-Olam was asked to rescue this study ongoing in France and Belgium. We recommended Poland to the sponsor and began regulatory submission promptly. Our goal was 20 patients in 12 weeks of enrollment with 5 sites. All patients were enrolled in just 8 weeks.
Each year the search for qualified patients to participate in clinical trials increases. Boasting large patient populations, expedient regulatory processes and a competitive cost structure, Turkey is an up-and-coming location for savvy clinical trial managers.
Turkey can contribute significant patient data to future clinical trials as it offers:
Pharm-Olam’s Conducting Clinical Trials in Turkey Resource Guide offers a detailed overview of the country’s research environment.
Pharm-Olam was contracted to provide services for a Phase III study that was to be conducted with 26 sites in Russia, Serbia, Bosnia, Latvia, and Lithuania to determine optimal dose versus adverse events. The study required 960 global patients of which Pharm-Olam was given a target of 345 patients. Pharm-Olam recruited 400 patients while staying ahead of schedule when the global goal was achieved.
Boasting strong patient enrollment rates, naive patient populations, enthusiastic physicians and a favorable cost structure – Belarus has much to offer life science companies as a location for clinical trials. These benefits, combined with the low number of trials currently being conducted, means that Belarus is an undiscovered gem for savvy clinical trial managers.
In this whitepaper, presented by Pharm-Olam International, you will learn:
Over the past decade, biopharmaceutical companies have increasingly turned to emerging markets as a way to reduce clinical trial costs and timelines. Areas such as Eastern Europe, India, and Latin America—with their ready population of treatment naïve patients—can be an answer to the intense competition for patients seen in developed markets. Many of the countries within these regions may now be considered as “emerged” countries but yet, conducting trials in these regions does require some special attention and expertise. Before deciding to conduct studies in these areas, companies should have a full appreciation for the ethical, medical, regulatory, legal, and operational hurdles that must be surmounted for success. Here we highlight a number of those issues and offer our recommendations for how sponsor companies can deal with them effectively.
Sponsors’ interest in emerging markets as loci for clinical trials has been mounting for at least a decade. In 2011, this phenomenon reached a tipping point: for the first time, more data were submitted to the European Medicines Agency in marketing-authorization applications on patients from outside of Europe and North American than from within those areas. While the “Rest of the World” designation includes some mature markets such as Australia and Japan, there is, nonetheless, a clear takeaway: emerging markets have become a hot bed of trial activity.
Pharm-Olam was selected as a regional provider in Western Europe, Eastern Europe and South Africa on 2 studies involving hospitalized ABSSSi patients. Pharm-Olam provided a full service offering including Feasibility, Site Selection, Investigator Meetings, Regulatory, Blinded and Unblinded Monitoring, Project Management, and local Medical Monitoring services. At study close out, Pharm-Olam completed enrollment using only 41 out of the 49 planned sites.
Since 1990, the number of clinical trials performed in Russia has grown rapidly, from 292 in 2002 to 563 in 2007. Russia’s large population and centralized health care system are two aspects of its environment that make Russia so conducive to clinical trials. Pharm-Olam’s “Clinical Trials in Russia, The Promise and the Approach ” Whitepaper details how to tap into the potential the Russian market has to offer.
The Whitepaper highlights:
Pharm-Olam was selected to provide development services for a Phase III study, which was designed to address the efficacy and safety of a compound for pulmonary arterial hypertension patients. This study originally required 670 patients across the globe, but the enrollment was later increased to 1,150 due to study design changes. Pharm-Olam played an integral part in the enrollment of the additional patients, providing 45% more patients than originally tasked.
Despite all of the careful planning that goes into clinical trials, there’s one thing that sponsors don’t plan on: the need to transfer responsibility for conducting the trial to a new Contract Research Organization (CRO) part way through a trial. Such “rescue” situations are complex and stressful for all involved.
Pharm-Olam was selected to provide Project Management, Monitoring, and Regulatory services for the sponsor of a Phase II dermatology study in glabellar lines. The recruitment timelines were very short (160 patients within 4 months, 8 sites). The challenges encountered in this study included performing SEV and submission in 3 weeks to ensure prompt recruitment and then to manage the high recruitment rate at each site.
Pharm-Olam was contracted to perform and manage all aspects of a phase I/II study to evaluate the PK response of the study compound implanted in patients with Acromegaly. The study was conducted in 5 sites in Russia and Bulgaria. Pharm-Olam provided a full-service solution that included Data Management, CRF development, Clinical Monitoring, Project Management, Safety Monitoring, and Medical Writing.
The sponsor of this Phase III study in Crohn’s disease required 595 patients globally which was conducted by several regional CROs involving over 170 sites in 28 countries. The study sponsor was not satisfied with the performance of their Eastern European CRO and chose to transfer responsibility to Pharm-Olam.
As the most common healthcare-related infection in intensive care units, and one of the most dreaded complications of in-hospital care, ventilator-associated pneumonia (VAP) is a cause for serious concern and demands meticulous care efforts to be taken. Pharm-Olam is proud to be partnering with a progressive drug development company in their search for a solution when a VAP diagnosis is made.