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Alina Iordache, in her capacity as the Lead Project Manager Europe, assumes the responsibility of strategically developing and providing medical oversight for the clinical trials conducted by our organization. Additionally, she supervises the clinical and medical affairs, pharmacovigilance, strategic regulatory, and data management and medical writing teams.
Alina possesses a wealth of industry experience spanning 15 years in the fields of medical, safety, quality assurance, regulatory affairs, and training, which she brings to bear in her current position. Additionally, she possesses a total of twelve years of extensive clinical research experience, during which she served as an international project manager for more than 200 clinical studies.
Alina has provided support to various therapeutic domains through her work, and she now maintains an active registered nurse license. Since 2020, she has held the designation of a QPPV given by European Medicine Agency (EMA).
Alina successfully obtained her MSc in Psychology from Pitesti University in Romania, followed by a Registered Nurse Degree from “FEG” College of Pitesti, also in Romania.
Sontoshi Patro is a seasoned clinical research professional with 20 years of experience in practicing medicine, research, development, and program management, encompassing both traditional drugs and cell therapies. She has been appointed to the Review Boards of Baylor College of Medicine, Texas Children’s Hospital and MD Anderson Cancer Center as a scientific reviewer for all therapeutic areas with primary focus on oncology studies.
With several years of industry experience, in clinical, operational leadership roles, she oversaw the clinical development programs for conventional full-service studies, and decentralized trials, and provided regulatory support for IND/BLA applications. She received her medical degree from Berhampur university, Translational research education from NIH, training in Genetics from Harvard (office for external education) and MBA from TWU. Her unique experience and expertise in leveraging R&D Solutions in evidence-driven trial design enables her to achieve operational excellence and optimize trial execution.
Professional in Clinical Operations and Project Management with over 25 years of experience in Drug Development and Clinical Research.
Her experience is related to lead complex programs and studies at global level, i.e AbbVie and Merck , combined with years working in clinical operations and Project management in the pharma, CROs and Biotech industry as, GSK, Novartis, IQVIA etc,
Teresa is making an effort to expand our operations into the business zones of Israel, South America and Japan because these zones are beneficial to our company.
Teresa’s professional network includes people in the pharmaceutical industry in both the American continent , Europe and Intercontinental regions . for our successful expansion it is critical her expertise working for biotech businesses and that she is actively involved in South American affairs.
Dr. Peter Kaiser is tasked with formulating the overarching vision and executing the corresponding strategy for the clinical Quality Assurance department. The scope of this responsibility encompasses the formulation, implementation, and sustenance of audit strategies that are rooted in risk assessment. These strategies are specifically designed to scrutinize both internal and external audits pertaining to Good Clinical Practice (GCP).
The primary objective of these audits is to ascertain that clinical trials are conducted in strict adherence to relevant regulations, guidelines outlined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), established procedures by CEBIS, and clinical trial protocols.
Peter is tasked with the deployment of comprehensive GCP inspection readiness plans. This responsibility entails the overall administration of a sizable cross-functional team consisting of colleagues from the CEBIS organization. Additionally, Peter has responsibility for the establishment, upkeep, and ongoing enhancement of departmental protocols and practices. They also provide assistance in implementing and continuously improving GCP systems. This role facilitates and encourages the establishment of a GCP (Good Clinical Practice) compliant setting with both internal and external stakeholders, while simultaneously assuring the utilization of the established Quality Systems of CEBIS. Peter holds the responsibility of overseeing and managing a team of direct reports, which may include contracted Consultants. This individual is required to demonstrate exceptional organizational skills and exemplify strong leadership qualities. This job serves as the internal subject matter expert within the Quality Assurance department of GCP.
Inder oversees the complete spectrum of clinical supply chain management, encompassing tasks such as sourcing comparators, manufacturing IMP/placebo, handling imports, managing storage, and overseeing global distribution.
Over the years, he has cultivated valuable collaborations with suppliers and affiliated entities. With a professional background that spans various global locations and includes prominent organizations like Bayer, Mylan Pharmaceuticals, and Shoppers Drug Mart, Inder brings his wealth of experience to the forefront in supporting CEBIS and its partners in their clinical trials, ensuring the smooth operation of supply chain management.
Dr. Sheriff is a dynamic leader in clinical research having more than 23 years of experience in the field, and he was formally trained as a physician and has undertaken a variety of entrepreneurial ventures as well.
He has spent over 25 years in the medical field working in hospitals, clinical research organizations, and assisting pharmaceutical companies worldwide in their drug development process.
In addition to his expertise in clinical research, he has conducted research on global health issues that benefited society.
He has participated in research projects in India, the US, Canada, Japan, Europe, Middle East, Asia, and Africa, and has served as a consultant on clinical research for several US and European pharmaceutical companies. Additionally, he has advised sponsors on regulatory compliance requirements and interacted with regulatory authorities during regulatory audits.
In India, Southeast Asia, and the Middle East, Dr Sheriff advises on building relationships and provides local insight into the pharmaceutical and drug device industries. Furthermore, he works with operations in building client-focused teams.
Dr. Kashif Haq, a seasoned professional with over two decades’ experience in drug development and clinical research. With an impressive track record working within the Pharmaceutical Industry, Kashif brings a wealth of knowledge and expertise to the field.
Dr. Haq’s experience spans across various domains, including CRO operations, system development, CRO setup, quality management, life science training, business development (clinical research and formulations), project management, and global supply chain management.
Throughout his distinguished career, Dr. Haq has demonstrated exceptional leadership qualities. He has consistently and effectively led cross-functional teams, successfully navigating complex challenges both in India and during international assignments.
Dr. Haq’s unique perspective and proficiency in the aforementioned areas makes him a valuable asset to any organization.
A highly experienced software developer and project manager, he has 11+ years of experience in full-stack development of enterprise-level Cloud applications and has spent 8+ years in areas of Project Management and End-User Support. With sound knowledge of Data Management Practices, Designing, Business Process, and Process Validations in Clinical Research domain.
Even if you are still in the planning stages of your project, you are more than welcome to submit a request to us. We can assist you with a quotation or create a proposal for you based on the minimum information you can provide.
