APRON Biotechnology, established in June 2020 is the first contract research organization, undertaking the mission of the organization in both preclinical and clinical trials in drug research in Turkey.
With our experienced team of having more than 16 years, we provide special services to you both clinical and preclinical (invitro and invivio) in the pharmaceutical industry.
Not only the planning, execution, monitoring, data analysis and reporting services of clinical trials with its senior team; we also have a well-equipped team to plan, conduct, monitor, data analysis and report preclinical studies.
APRON Biotechnology, performing research organizations to carry out the preclinical and clinical studies of GLP and GMP conditions for new drug candidates. It undertakes extensive work to bring together the infrastructure of the laboratory services and the services needed in this area in Turkey by creating an organization having mission to bring services for the discovery of new medicines together.
We organize training programs for both industry and researchers. We target increasing University-Industry partnerships to ensure the scope of pharmaceutical R&D activities. With the integration of the university researchers and working environment to pharmaceutical industry, we bring platforms together, which will contribute to the development of new patented product in Turkey. Thus, targeting to reduce dependence to abroad in drug R&D efforts. With efficient use of the budget allocated to preclinical and clinical work environment, this may diverted to Turkey's own research R&D activities. Hereby, our main goal is to undertake the organization of all preclinical and clinical studies of domestic national drug candidates.
With the help of the management systems we have established, within the framework of national and international legal regulations; We bring together institutions and organizations that provide services in accordance with GLP, GMP and GCP standards required by the pharmaceutical industry.
Based on national and international standards, we offer timely reliable service to our customers within the framework of legal legislation, with independent, impartial, well educated, professional and having technical competence, constantly self-renewing and improving staff.
We closely follow up-to-date developments regarding the subjects within the scope of the services, inform the relevant parties and constantly improve ourselves.
We contribute to the knowledge and technology production of our country thanks to University-Industry Cooperation projects in Pharmaceutical R&D and Product Studies.
In preclinical and clinical studies, we offer analytical approaches for the integration of stakeholders and achieving results.
We ensure the sustainability of all these factors.
Based on the Total Quality philosophy, we bring the institutions and units to their goals in a team spirit.
Design, monitoring and reporting of necessary preclinical studies related to drug efficacy
Design, monitoring and reporting of necessary preclinical studies related to drug safety
Organization, monitoring and reporting of in silico, in vitro and in vivo studies related to new drug candidates in laboratories that comply with GLP requirements
Design, monitoring and reporting of preclinical toxicological tests of drug/drug candidate under GLP conditions
Bringing together the stakeholders of the pharmaceutical/pharmaceutical companies through University-Industry cooperation projects, ensuring that the infrastructure facilities are brought together in accordance with GLP and GMP requirements
Study Design/Protocol Design
Medical Writing
Risk Management
Data Collection Form (CRF) and BGOF Design
Ethics Committee and TITCK File Preparation
Budget Management
TITCK Drug Import Permit Procedures
Custom Clearance of Drugs From Customs
Research Material Storage
Research Material Distribution
Monitoring and Center Management
Center Organization Management (integration of field officials)
Collection of Research Materials from the Centers
Research Material Destruction Operations
Data management, statistical data analysis and reporting
Preparation of final report
Study Design / Protocol Design
Medical Writing
Risk Management
Data Collection Form (CRF) and BGOF Design
Ethics Committee and TITCK File Preparation
Budget Management
Monitoring and Center Management
Custom Clearance of Drugs From Customs
Central Organization Management (integration of field officials)
Data management, statistical data analysis and reporting
Preparation of final report and CE application file
Study Design / Protocol Design
Medical Writing
Risk Management
Data Collection Form (CRF) and BGOF Design
Ethics Committee and TITCK File Preparation
Budget Management
Monitoring and Center Management
Central Organization Management (integration of field officials)
Data management, statistical data analysis and reporting
Preparation of final report and CE application file
• Designing preclinical studies under OECD regulations and organizing preclinical studies in GLP laboratories
• Immunotoxicity • Immunogenicity • Immuno efficacy • Functional studies • Anti-drug Antibodies (ADA) Tests
• Testing of viral incidental agents
• Toxicity Studies • Medical devices
• Medical Writing is part of legal documents and is conducted by our experienced staff. What's more, local authors are at your disposal in multinational essays. • Experienced doctors and scientifically trained staff take care of our final product. • We prepare high quality research documents. • Compliance with all relevant industry-specific guidelines is acceptable, as evidenced by hundreds of successful applications made by our customers.
CONTACT US• Establishing a drug development program • Providing scientific advice with the target authority • Regulatory advice on CHMP and FDA guidelines • Feasibility evaluation • Evaluation of pharmacokinetic data based on in-house database and scientific sources • Validated sample size evaluation
CONTACT US• Identifying risks such as legal risks, environmental risks, market risks, regulatory risks, • Analysis of risks • Assessing and ranking risks for priority • Treating risk • Monitoring and reviewing the risk
CONTACT US• To conduct external and internal audits, deviation and change management
• Addressing and monitoring of corrective and preventive actions
• Preparation and coordination of all trial-related documents • Supervision of all trial-related procedures • Securing the timeline with all collaborating partners • Coordination of Clinical Trial Presentations in Ethics Committees and Regulatory Authorities • Receiving regulatory presentations • Preparation of monitoring plans, overview of monitoring activities and reporting • Sample organization and supervision of all logistics processes related to the trial, including shipments • Provide Project Status Reports • Researchers' Meeting organization
CONTACT US• Obtaining Clinical Study Approvals from local and international authorities • Providing required documents to be submitted to Ethics Committee(s) and Regulatory Authorities • Compiling per country shipping package for Ethics Committee(s) and Regulatory Authorities • Required translations by country • Management of insurance covered per country • Providing and managing contracts with sites and researchers as required on a country basis • Interaction with Regulatory Authorities before, during and after the submission procedure
CONTACT US• Interaction with clinical centers and researchers • Close communication and reporting with the central project management team at the center • Organization of local team meetings • Researchers and field fee negotiation • Contract management and conclusion for inspectors and sites • Administrative payments to researchers and sites
CONTACT US• Including field feasibility assessment. feasibility survey circulation • Site selection • Monitoring the visits of clinical centers • Preparation of monitoring reports • Interaction with clinical centers and researchers • Close communication and reporting to the central project management at the center
CONTACT US• Biometric input during the development of clinical trial protocol • Sample size estimation • Randomization (Oracle Clinical) • Statistical Analysis Plan / Report • Statistical analysis and reporting for clinical trial report • Database integration • Electronic data transfer
CONTACT US• Data Management/Verification Plan • Data Management/Verification Report
• Insurance of data security and integrity
• Obtaining local voluntary insurance for clinical trial participants • Temperature-controlled delivery of bioanalytical samples to central laboratories in Europe
CONTACT USAn experienced team with professional backgrounds in a wide variety of fields...
RELIABLE AND PERFECT
She holds a bachelor's degree from Hacettepe University Faculty of Pharmacy.
TUBITAK:As a fellow of TUBITAK, she completed her thesis at Balearic Islands University in Mallorca, Spain. She completed the project.
Then she worked as a postdoctoral researcher at the University of Basel, Switzerland.
As the Deputy Dean of the Faculty of Pharmacy at Erciyes University, she was responsible for the education accreditation programs for 8 years.
She went to the USA for a joint project.
She started to work on natural products for the prevention and treatment of cancer at this university.She examined the effects of herbal medicines on neurodegenerative diseases and cancer in our country.
She has completed 9 TUBITAK projects, 45 Local Research Projects, over 55 publications and over 100 papers presented in some national and international meetings.
In 2015, she started an international congress series of"Natural Products in Cancer Prevention and Treatment".
Since then, she brings industry and academia together in this conference series twice a year.
In 2016, she served as the Manager of Erciyes University Pharmaceutical Application and Research Center, which is a research center accredited with ISO 9001:2015, ISO 10002:2018, ISO 14001:2015, ISO 45001:2018, GLP, GMP, ISO 27001 and ISO 13485.
The Center is designed to carry out R&D studies and provide services for natural, semi-synthetic, synthetic and biotechnologically sourced food supplements, cosmetics, traditional herbal medicine products, medical devices, pesticides, veterinary drugs and human medicine R&D studies.
In addition, the Center provides an accredited analysis laboratory for pharmaceutical research and necessary preclinical tests and analyzes in pharmaceutical products.
Pharmaceuticals for therapeutic drug monitoring studies through bioanalytical analyzes, pharmacogenetic tests and toxicological analysis in biological and non-biological samples in clinical studies.Center has GLP certificate for application studies.
Professor Aycan is Dean of Faculty of Pharmacy and has founded APRON Biotechnology, where she provides CRO services for Clinical Research.
She has more than 20 years of experience in proposal writing, pre-clinical and clinical research study design.
Dr. Demirpolat is a graduate of Erciyes University, Department of Pharmacy. He has experience as a faculty member and clinical research pharmacist. He held managerial positions as vice dean and vice director in drug research and practice within the faculty. He worked in nearly 100 bioequivalence clinical studies as a pharmacist and pharmacologist. He studied cancer molecular mechanisms, genetic variances and polymorphs, clinical trials. He can apply in vitro molecular techniques such as cell culture, western blot, pcr and elisa kits. He is the co-founder of APRON Biotechnology.
Dr. Soydan graduated from Erciyes University Faculty of Medicine in 1999. Between 2004-2021, he worked as a co-researcher at Erciyes University GCP Center. Afterwards, he assumed the role of Quality Assurance Manager. He participated in more than 100 bioequivalence studies and Phase 1 (first in human) studies. Between 2019-2021, he worked as a QA at the Erciyes University Pharmaceutical Research and Application Center. Erciyes University Pharmaceutical Application and Research Center is accredited with ISO 9001:2015, ISO 10002:2018, ISO 14001:2015, ISO 45001:2018, GLP, GMP, ISO 27001 and ISO 13485. He has worked as Assurance Manager. He has experience in preparing clinical study protocols, volunteer/patient informed consent forms and case report forms. He has experience in preparing the ethics committee and IRB application files. He is the co-founder of APRON Biotechnology. He is a PhD student in pharmacology.
If you need support for your projects, you can contact us.