Your Expert for Medical Device and Pharma Research Consulting

Support and Consulting for Medical Device and Pharma research studies in all study phases

Your expert for Life Science Research

kim-scaled-e1615194907691.jpg

Support and Consulting for Medical Device and Pharmacological studies in all study phases

Your expert for Life Science Research

"Benefit from more than a decade of hands-on experience and networking capabilities in life science research & development. Intelligent and effective solutions are the key advantage for your project."

ABOUT ME

With over a decade of practical experience in life science research and development, I bring extensive knowledge in various therapeutic areas such as Oncology, Central Nervous System, and Cardiovascular. This allows me to approach projects from multiple perspectives. Throughout my career, I have excelled in diverse work environments and held various positions, including providing business support, consulting, workshops, and mentoring/coaching for start-up companies and corporate structures in the medical devices, pharmacology, and biotechnology sectors.

As a network partner with a strong international focus, my professional profile revolves around clinical research and development, with expertise in operational processes and interdisciplinary collaboration.

Throughout my career, I have established and fostered valuable partnerships with professionals and organizations around the world. This has enabled me to contribute to and drive clinical research initiatives on a global scale. I thrive in diverse and multicultural environments, leveraging my extensive network to bring together experts from various disciplines.

My primary focus lies in the field of clinical research and development. I possess a deep understanding of the intricacies involved in designing, implementing, and managing clinical trials. From protocol development to data analysis, I am well-versed in the entire research lifecycle. I have a proven track record of successfully navigating regulatory frameworks and ensuring compliance with international standards.

Operational efficiency is one of my key strengths. I excel in optimizing processes to streamline clinical operations, enhance productivity, and meet project timelines. By implementing innovative strategies and leveraging cutting-edge technologies, I strive to enhance the efficiency and effectiveness of clinical trials.

What sets me apart is my interdisciplinary approach. I am comfortable working with professionals from diverse backgrounds, such as medical practitioners, scientists, statisticians, and regulatory experts. By fostering collaboration and knowledge sharing, I facilitate the integration of different perspectives, leading to comprehensive and well-rounded research outcomes.

As a network partner with an international outlook, my professional profile is centered around clinical research and development. I am skilled in optimizing operational processes and thrive in interdisciplinary environments. My expertise and experience enable me to contribute effectively to global clinical research initiatives and drive impactful advancements in the field.

I continually stay updated with national and international regulations and activities to ensure a high industry-specific quality standard in my professional endeavors. I actively participate in association activities and contribute to research projects. My expertise extends to various functional areas, including Clinical Project Management, Study Start-Up Management, Regulatory Affairs (Pharma, MDR), Clinical Research Associate (CRA) roles, and Clinical Operations Specialist. Proficient knowledge and skills in utilizing diverse clinical software and database systems, coupled with the ability to implement digital, centralized, and decentralized study settings, are among my key strengths.

ABOUT ME

With over a decade of practical experience in life science research and development, I bring extensive knowledge in various therapeutic areas such as Oncology, Central Nervous System, and Cardiovascular. This allows me to approach projects from multiple perspectives. Throughout my career, I have excelled in diverse work environments and held various positions, including providing business support, consulting, workshops, and mentoring/coaching for start-up companies and corporate structures in the medical devices, pharmacology, and biotechnology sectors.

As a network partner with a strong international focus, my professional profile revolves around clinical research and development, with expertise in operational processes and interdisciplinary collaboration.

Throughout my career, I have established and fostered valuable partnerships with professionals and organizations around the world. This has enabled me to contribute to and drive clinical research initiatives on a global scale. I thrive in diverse and multicultural environments, leveraging my extensive network to bring together experts from various disciplines.

My primary focus lies in the field of clinical research and development. I possess a deep understanding of the intricacies involved in designing, implementing, and managing clinical trials. From protocol development to data analysis, I am well-versed in the entire research lifecycle. I have a proven track record of successfully navigating regulatory frameworks and ensuring compliance with international standards.

Operational efficiency is one of my key strengths. I excel in optimizing processes to streamline clinical operations, enhance productivity, and meet project timelines. By implementing innovative strategies and leveraging cutting-edge technologies, I strive to enhance the efficiency and effectiveness of clinical trials.

What sets me apart is my interdisciplinary approach. I am comfortable working with professionals from diverse backgrounds, such as medical practitioners, scientists, statisticians, and regulatory experts. By fostering collaboration and knowledge sharing, I facilitate the integration of different perspectives, leading to comprehensive and well-rounded research outcomes.

As a network partner with an international outlook, my professional profile is centered around clinical research and development. I am skilled in optimizing operational processes and thrive in interdisciplinary environments. My expertise and experience enable me to contribute effectively to global clinical research initiatives and drive impactful advancements in the field.

I continually stay updated with national and international regulations and activities to ensure a high industry-specific quality standard in my professional endeavors. I actively participate in association activities and contribute to research projects. My expertise extends to various functional areas, including Clinical Project Management, Study Start-Up Management, Regulatory Affairs (Pharma, MDR), Clinical Research Associate (CRA) roles, and Clinical Operations Specialist. Proficient knowledge and skills in utilizing diverse clinical software and database systems, coupled with the ability to implement digital, centralized, and decentralized study settings, are among my key strengths

EXPERTISES

I develop and advise in different functional areas, but not limited to: Clinical Project Manager, Study Start Up Manager, Regulatory Affairs (Pharma, MDR), CRA, Clinical Operations Specialist. My specialisation is the integrated supervision of different project development stages, scopes of requirements and an agile interim solution for individual, targeted or even overall project management. I have excellent knowledge and skills in various clinical software/database systems and digital, centralised/decentralised study settings.

EXPERTISES

I develop and advise in different functional areas, but not limited to: Clinical Project Manager, Study Start Up Manager, Regulatory Affairs (Pharma, MDR), CRA, Clinical Operations Specialist. My specialisation is the integrated supervision of different project development stages, scopes of requirements and an agile interim solution for individual, targeted or even overall project management. I have excellent knowledge and skills in various clinical software/database systems and digital, centralised/decentralised study settings.

COMPETENCIES

  • Project Management
  • Regulatory Consultancy and Support
  • Monitoring
  • Medical Device Regulation
  • Post Market Strategy
  • Quality Assurance
  • Auditing
  • Oncolog
  • Neurology
  • Cardiovascular
  • Consultancy
  • Medical Device
  • Biotechnology
  • Feasibility
  • Study Start Up
  • Patient Recruitment

STUDY PHASES AND THERAPEUTIC AREAS

  • II Oncology /Breast Cancer
  • II Oncology/PreventionTherapy -cisplatin- or
    anthracycline/cyclophosphamide (AC)-based chemotherapy
  • II Oncology/Ovar Cancer Inhibitor Therapy
  • I Oncology/Melanoma RNA-Based Cancer Therapy
  • III Oncology/Breast Cancer (Adjuvant Therapy)
  • I-III Oncology (relapsed/refractory) Multiple Myeloma /AML (Dose finding, Children/Adolescent
  • Ib Oncology Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Therapy
  • II Oncology-Chronic Lymphatic Leucemia: Combination Therapy Retreatment in Patients with Recurring Disease
  • I Oncology Safety and Pharmacokinetics in Pediatric and Young Adult Patients with Relapsed or Refractory Malignancies
  • Ib Oncology Open-Label Study in Combination Therapy in Subjects with Relapsed or Refractory Multiple Myeloma
  • II Oncology Non-small Cell Lung Cancer AB based therapies
  • III Oncology/Colorectal Cancer DNA-Based Cancer Therapy
  • I Immunology/TB Vaccine
  • I CNS/Analgetic
    III-IV CNS/ADHD (BTM Study)
    III-IV CNS/Binge Eating Disorder (BTM Study)
  • III CNS/ Moderate and severe traumatic brain injury
  • IV CNS/ Chronic Pain Relief (SCS)
  • I CNS/Movement Disorders (DBS)
  • II CNS/ ALS – Complement Inhibitors
  • II CNS/ Deramtomyositis – Complement Inhibitors
  • III CNS/PTPS – Psychoactive Substances (BTM)
  • II CV/ Antithrombotic
  • III CV/Antidot Therapy in Patients receiving Factor Xa
  • II CV/Renal Denervation/ Reducing Arterial Blood Pressure Phase
  • II CV/CNS Heart Failure (VNS)
  • III CV/Renal High Risk for Acute Kidney Injury (AKI) following Cardiac Surgery
  • II Dose finding/ Assess the Efficacy and Safety of Orally Administered Lipid lowering agents in Patients with Hypertriglyceridemia and Type 2 Diabetes
  • II Infertility
  • II-III Ophthalmology /Macular Edema
  • Feasibility Study Ophthalmology /Refractive Eye Disease
  • II-IV Respiratory/COPD
  • I Dermatology/Hair Growth
  • II Dermatology/ Intervention of acute Atopic Dermatitis
  • I Dermatology/Aesthetics
  • I Renal/Hyperactive Bladder
  • I Renal Failure/ Anemia

COMPETENCIES

Realisation
  • Project Management
  • Regulatory Consultancy and Support
  • Monitoring
  • Medical Device Regulation
  • Post Market Strategy
  • Quality Assurance
  • Auditing
  • Oncolog
  • Neurology
  • Cardiovascular
  • Consultancy
  • Medical Device
  • Biotechnology
  • Feasibility
  • Study Start Up
  • Patient Recruitment
Kick-Off Workshop

STUDY PHASES AND THERAPEUTIC AREAS

  • II Oncology /Breast Cancer
  • II Oncology/PreventionTherapy -cisplatin- or
    anthracycline/cyclophosphamide (AC)-based chemotherapy
  • II Oncology/Ovar Cancer Inhibitor Therapy
  • I Oncology/Melanoma RNA-Based Cancer Therapy
  • III Oncology/Breast Cancer (Adjuvant Therapy)
  • I-III Oncology (relapsed/refractory) Multiple Myeloma /AML (Dose finding, Children/Adolescent
  • Ib Oncology Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Therapy
  • II Oncology-Chronic Lymphatic Leucemia: Combination Therapy Retreatment in Patients with Recurring Disease
  • I Oncology Safety and Pharmacokinetics in Pediatric and Young Adult Patients with Relapsed or Refractory Malignancies
  • Ib Oncology Open-Label Study in Combination Therapy in Subjects with Relapsed or Refractory Multiple Myeloma
  • II Oncology Non-small Cell Lung Cancer AB based therapies
  • III Oncology/Colorectal Cancer DNA-Based Cancer Therapy
  • I Immunology/TB Vaccine
  • I CNS/Analgetic
    III-IV CNS/ADHD (BTM Study)
    III-IV CNS/Binge Eating Disorder (BTM Study)
  • III CNS/ Moderate and severe traumatic brain injury
  • IV CNS/ Chronic Pain Relief (SCS)
  • I CNS/Movement Disorders (DBS)
  • II CNS/ ALS – Complement Inhibitors
  • II CNS/ Deramtomyositis – Complement Inhibitors
  • III CNS/PTPS – Psychoactive Substances (BTM)
  • II CV/ Antithrombotic
  • III CV/Antidot Therapy in Patients receiving Factor Xa
  • II CV/Renal Denervation/ Reducing Arterial Blood Pressure Phase
  • II CV/CNS Heart Failure (VNS)
  • III CV/Renal High Risk for Acute Kidney Injury (AKI) following Cardiac Surgery
  • II Dose finding/ Assess the Efficacy and Safety of Orally Administered Lipid lowering agents in Patients with Hypertriglyceridemia and Type 2 Diabetes
  • II Infertility
  • II-III Ophthalmology /Macular Edema
  • Feasibility Study Ophthalmology /Refractive Eye Disease
  • II-IV Respiratory/COPD
  • I Dermatology/Hair Growth
  • II Dermatology/ Intervention of acute Atopic Dermatitis
  • I Dermatology/Aesthetics
  • I Renal/Hyperactive Bladder
  • I Renal Failure/ Anemia

REA Research Experts Alliance by Kim Eilitz

CONTACT US

E-Mail: success@rea.works