IPHARMA CRO

A new service from IPHARMA: control over the progress of a trial in a “one-stop-shop” mode. We continue to improve our IT solutions for organizing and conducting clinical trials (CT), while remaining open to sponsors. Our goal is to increase the sponsor's confidence that the study is proceeding as planned. IPHARMA has developed a new service that allows employees of sponsor companies to monitor the progress of clinical trials. The platform is integrated with the system of electronic collection and analysis of participant data and provides information on participant enrollment, undesirable and serious adverse events, responses to inquiries and completion of individual registration cards. The service is called "Sponsor's Dashboard" and is available as a one-stop shop for quick and convenient access to study data. Employees of the sponsoring companies can track up-to-date information and promptly respond to any changes. The platform provides an opportunity to view data in both raw and aggregated formats. This makes it possible to use them for internal corporate reports and to provide them to the company's management. Data in raw format represent raw information obtained from an electronic data collection system. They can be useful for detailed analysis and understanding of specific aspects of the study. Aggregated data are summarized information that can be useful for quickly reviewing the progress of a study and identifying general trends. Thanks to the new service, employees of sponsoring companies are able to focus on discussing specific issues with the project manager, rather than spending time searching for and analyzing information about the progress of the study. This innovative solution from IPHARMA significantly simplifies the process of controlling clinical trials and increases the efficiency of the sponsoring companies' employees. The service has already received positive feedback from the first users and continues to evolve to provide even more convenient tools for trial management.

Specifics of clinical trials of radiopharmaceutical drugs. It’s impossible to imagine modern medicine without radiological methods of diagnostics and treatment of patients. Radiotherapy consists of a local, targeted treatment of ionizing radiation and is usually used in oncology for treatment of malignant tumors. During this process, healthy tissues near the tumors are also affected, however healthy cells eventually regenerate, unlike cancer cells. There are three main types of radiotherapy: •            Contact/Brachytherapy: the radiation source is in direct contact with the patients’ tissue; •            Remote: the source is at a certain distance from the patient; •            Radionuclear: the RPS is injected into the patient’s blood. Only RPS with high affinity to the tumor are suitable. They can precisely direct radiation dosages at the tumor and its metastases, minimizing the effect on healthy tissues and reducing the side effects. To register a radiopharmaceutical substance, it is mandatory to conduct pre-clinical and clinical trials. Pre-clinical and clinical trials of radiopharmaceutical substances are similar to trials of chemotherapy drugs: •            Since radiopharmaceutical substances are highly toxic, healthy volunteers do not participate in phase I trials. Patients with the corresponding illnesses participate instead. •            In trials of both radiopharmaceutical substances and other chemotherapy drugs placebo is usually not used since it would be unethical for the patients. However, unlike other drugs, RPS are radioactive, which introduces certain specifics to their study and administration. •            RPS are direct radiation sources, which means that they affect their surroundings, the patient, medical personnel and those who produce them. Therefore, it is necessary to strictly follow the federal laws. •            Radioactivity negatively affects biological systems, so radionuclear substances with a short-half life are particularly valued, which reduces the time of the patient’s exposure to them. The production of RPS must be efficient and be located in proximity to the medical center where they are used. It is important to precisely organize the logistics of RPS, bearing in mind that the activity of the drug is reduced by the minute. Often, the drug is logged not by weight but by level of its activity in megabecquerel (MBq). Clinical trials of radiopharmaceutical substances are some of the most complicated types of studies. iPharma has successful experience in conducting clinical trials with RPS, obtaining all the necessary permits in compliance with the main sanitary requirements of assurance of radiation safety (MSRARS) and organizing the logistics. In order to successfully conduct RPS trials, it is crucial that the medical personnel, RPS developers and the clinical research organization (CRO) work in tandem. #ipharma#clinicaltrials#trials

IPHARMA: a new step on the international arena. IPHARMA, together with their partners, launched the first international clinical trial in Australia. This is a significant event for the company, which opens new perspectives and opportunities for growth on the international market. IPHARMA is a company which specializes in development and production of innovational medical drugs. We have extensive experience, including participation in international project management, data management and biostatistics. These allow IPHARMA to feel confident on the international market and compete with leading companies in the sector. The launch of the first clinical trial in Australia is an important step for IPHARMA. It will allow the company to broaden its geographical presence, attract new partners and investors, as well as consolidate its positions on the global market. The clinical trial, launched by IPHARMA in Australia aims to study the effectiveness of a new medical drug. The trial is conducted in compliance with international quality and safety standards. The results will be published in scientific journals and presented at international conferences. We are certain that the launch of the first clinical trial in Australia will be the first stage of IPHARMA’s development as an international company. We are ready for cooperation with new partners and are open to new ideas and projects.  #clinicaltrials #Australia #IPHARMA #CRO #news

#clinicaltrials #clinicaltrialsEAEU #EEU #EAEU

The FDA's recent two-day workshop, mandated by the Food and Drug Omnibus Reform Act of 2022 (FDORA), brought forward essential strategies to enhance diversity in clinical trials. Here are the top insights: Broader Diversity Definitions: The FDA now includes pregnant individuals, the elderly, children, and those with intellectual or mental health conditions, moving towards more inclusive clinical trials. Importance of Early Planning: Panelists stressed expanding eligibility criteria from the outset and engaging diverse communities from Phase I to prevent recruitment delays. Data Collection and RWD Challenges: Standardizing data collection faces hurdles, especially with sensitive attributes like race and gender identity. The relevance of Real-World Data (RWD) was also discussed, emphasizing its fitness for purpose. Divergence in Expectations: Analysis of Project Equity revealed that while 87% of diversity plans had the recommended components, only 6% met the FDA’s expectations upon review. Collaborative Efforts for Diversity: Success in diversifying clinical trials requires efforts from all stakeholders. The FDA’s Patricia Cavazzoni noted the necessity of collaborative efforts in her opening remarks. Companies like Boehringer Ingelheim are introducing roles such as Clinical Trial Diversity Lead to support these initiatives. As the FDA prepares to issue new or updated guidance per FDORA's requirements, sponsors and CROs eagerly anticipate the forthcoming directives to better support diverse patient recruitment. #ClinicalTrials #ClinicalTrialDiversity #InclusiveResearch #HealthcareInnovation #PatientCentricity #RealWorldEvidence #DataIntegrity #RegulatoryCompliance #PublicHealth #BiomedicalResearch #DrugDevelopment #TherapeuticInnovation #EquitableHealthcare #DiverseClinicalTrials #InclusivityInHealth #ResearchEthics #CommunityEngagement #StakeholderCollaboration #GlobalHealth #FDA

The selection of a Contract Research Organization (CRO) for biometrics in 2024 will be more crucial than ever. In 2023, CROs conducted about 75% of global clinical trials, driven by their ability to deliver projects rapidly, cost-effectively, and in compliance with complex regulations. Key benefits of partnering with CROs include: Expedited Project Delivery: Utilizing streamlined processes to speed up trial timelines. Cost Savings: Efficient resource allocation reduces overall trial costs. Regulatory Expertise: Navigating global compliance with specialized knowledge. However, finding the right CRO in 2024 demands careful consideration of your project’s unique requirements and the CRO’s technological and regulatory capabilities. The right CRO partnership is more than a service agreement; it's a collaboration that can elevate your clinical trial's success in an evolving healthcare landscape. #ClinicalTrials2024 #CRO #Biometrics #HealthcareInnovation #ClinicalTrials

At iPharma, we recognize that biometrics is the backbone of successful clinical trial outcomes. After over ten years in the field and completing more than 170 trials across various therapeutic areas, we've honed key strategies for biometric success: Early Collaborations: Engaging biostatisticians and data managers from the outset is essential. Their early involvement can shape robust trial designs and streamline data collection strategies, setting a strong foundation for the entire study. Strategic Planning: A well-articulated Statistical Analysis Plan (SAP) is non-negotiable. It aligns the trial's objectives with appropriate statistical methods and result interpretations, ensuring clarity and direction. Data Integrity: The caliber of data underpins trial integrity. Implementing stringent data collection and management protocols ensures accuracy, completeness, and consistency, driving reliable trial results. Seamless Integration: Ensuring fluid communication among biostatisticians, SAS programmers, and data managers is vital. It fosters an integrated team approach, enhancing efficiency and productivity. Cost-Effectiveness: With the high costs associated with clinical trials, cost-effective biometric data collection, management, and analysis are imperative. It's about maximizing resource efficiency without compromising data quality. By championing these principles, iPharma continues to lead in the meticulous execution of clinical trials, delivering data you can trust. #iPharma #ClinicalTrials #Biometrics #Biostatistics #DataManagement #SASProgramming #Pharmaceuticals #HealthcareInnovation

On October 26th, the iPharma delegation, led by Development Director Anna Makarenko, attended the "Clinical Research Dialogues" conference organized by the Chamber of Commerce and Industry of St. Petersburg. This event brought together experts in the field of clinical research, which was structured into a plenary session and two thematic sections: 1️⃣ Bioequivalence Studies: This session focused on the peculiarities of local drug studies, biosimilars, regulatory aspects, and case studies. 2️⃣ Real World Evidence/Data (RW/RWD): The development within the EAEU context and the industry's challenges were discussed. Attendees included medical professionals, pharmaceutical companies, laboratories, and scientific and research centers such as the Center for Pharmaceutical Analytics, Exacte Labs, Meligen, and many others. The "Clinical Trials Dialogues" conference proved to be an invaluable platform for fostering collaborative discussions, exchanging innovative ideas, and setting new trends for the advancement of clinical research. #ClinicalTrials #Bioequivalence #RWE #EAEU #iPharma #Pharmaceuticals #HealthcareConferences

On October 18, 2023, the leading experts from iPharma's business development department joined the pivotal event at Skolkovo - "Industry Day." This annual gathering bridges the gap between the tech business sector, professionals, and the scientific community, fostering knowledge exchange and introducing cutting-edge developments. A standout session was the "Roundtable on Biomedicine and Neurotechnology." This segment illuminated the latest breakthroughs in the field and showcased scientific and clinical outcomes from collaborations with medical centers and industrial partners. Such events not only enhance professional expertise but also pave the way for novel collaborative endeavors and partnerships. Our heartfelt gratitude to the organizers for allowing us to be a part of this significant occasion! If you have any questions, require consultation, or wish to discuss potential collaboration, please feel free to reach out to Anna Makarenko