Our expertise in herbal medicinal products
The growing interest in natural healing methods and the increasing scientific evidence for the efficacy of herbal medicines have led to an upswing in this product category in clinical research over the past few years. At the same time, the special characteristics of herbal preparations present research with unique challenges that require specific expertise and customized solutions.
As a leading CRO in the field of phytotherapy, Mediconomics has many years of experience in planning and conducting clinical trials with herbal medicinal products. Our interdisciplinary team combines in-depth knowledge of the complex mechanisms of action of herbal extracts with comprehensive methodological expertise in clinical research. We understand the regulatory requirements as well as the needs of our clients in the pharmaceutical industry.
From study planning and implementation to the evaluation and publication of the results, we offer you customized solutions that meet the special challenges of phytotherapy research. Our aim is to support you in generating high-quality scientific evidence for your herbal medicinal products and thus contribute to the further development of phytotherapy.
Mediconomics offers comprehensive services for clinical trials in the field of phytotherapy. With our many years of experience, we support manufacturers of herbal medicinal products in conducting high-quality clinical trials
Special challenges of phytotherapy
Complex composition:
Herbal extracts contain numerous ingredients whose interaction must be taken into account. This poses particular challenges for the study design:
- Detection of possible synergistic or antagonistic effects
- Consideration of the overall effect instead of focusing on individual substances
- Development of suitable analytical methods for the characterization of complex extracts
Standardization:
We pay attention to precise standardization of the test preparations to ensure reproducible results. This includes
- Definition and control of relevant ingredients or lead substances
- Consideration of natural fluctuations in the composition
- Development and validation of suitable manufacturing processes
Special regulatory features:
Our experts are familiar with the special approval requirements for herbal medicinal products. These include
- Consideration of specific guidelines for herbal medicinal products
- Documentation of the traditional application
- Special features of the safety assessment of herbal preparations
Dose finding:
Determining the optimum dosage requires particular care:
- Consideration of traditional applications and empirical values
- Carrying out dose-finding studies taking into account the complex composition
- Evaluation of different dosage forms and extraction methods
Placebo control:
Placebo control poses a particular challenge with herbal preparations:
- Development of suitable placebos that correspond to the verum in appearance, smell and taste
- Consideration of possible non-specific effects due to sensory properties
- Evaluation of alternative study designs such as comparative studies with standard therapies
Long-term use and safety:
The evaluation of long-term use and safety requires specific approaches:
- Conducting long-term studies to record chronic effects
- Systematic recording and evaluation of undesirable effects
- Consideration of possible interactions with long-term use
By taking these specific challenges into account, we ensure that high-quality clinical trials are carried out that meet the special requirements of phytotherapy.
Study planning and design:
We develop customized study protocols taking into account the special features of herbal preparations. These include
- Selection of suitable endpoints and biomarkers
- Case number calculation and statistical planning
- Consideration of traditional areas of application
- Development of innovative study designs for complex herbal extracts
- Integration of patient-relevant outcomes
Regulatory Affairs:
Our team supports you in all regulatory aspects:
- Advice on specific requirements for herbal medicinal products
- Communication with authorities and ethics committees
- Preparation of approval documents
- Support in the creation of Investigator’s Brochures
- Advice on regulatory strategies for various markets
Patient recruitment:
We develop target group-specific strategies for the efficient recruitment of study participants:
- Identification of suitable study centers and investigators
- Development of recruitment materials and campaigns
- Use of digital recruitment tools and social media
- Training of study staff in recruitment techniques
- Continuous monitoring and optimization of recruitment
Clinical monitoring:
Our experienced monitors ensure that the study is conducted in compliance with GCP:
- Regular on-site and remote monitoring visits
- Ensuring compliance with the study protocol
- Checking the source data documentation
- Management and follow-up of queries
- Support in the preparation of audits and inspections
Data management and biostatistics:
We use validated eCRF systems and carry out complex statistical analyses:
- Development of customized databases and eCRFs
- Data validation and quality control
- Creation of statistical analysis plans
- Carrying out complex statistical evaluations
- Interpretation of the results in the context of phytotherapeutic peculiarities
Pharmacovigilance:
We take over the security management of your study:
- Recording and evaluation of adverse events
- Preparation of safety reports
- Management of SUSARs and other reporting obligations
- Training of study personnel on pharmacovigilance aspects
Project management:
Our experienced project management team coordinates all aspects of your study:
- Development of detailed project plans and timelines
- Budgeting and cost control
- Regular status reports and communication
- Risk management and problem solving
- Coordination of all stakeholders involved
Medical Writing:
We support you in all aspects of medical writing:
- Preparation of study protocols and amendments
- Writing clinical study reports
- Preparation of publications and congress contributions
- Creation of patient information and declarations of consent
Our quality standards:
Clinical trials with herbal medicinal products are conducted according to the highest quality standards:
- Compliance with GCP guidelines and regulatory requirements
- Consideration of specific guidelines for herbal medicinal products
- Regular internal and external audits
- Continuous training and further education for our staff
- Implementation of a comprehensive quality management system
- Close cooperation with experts in phytotherapy and naturopathy
Thanks to our comprehensive range of services and our network in phytotherapy, we can support you in the successful implementation of your clinical trial – from conception to publication of the results.
Locations
Maps
contact@mediconomics.com
+49 (0) 511 560 998-0
Call us
And what can we do for you?
Dr. (MD) Uwe Albrecht,
FIBMS, FFPM (Dis.), FICR, CSci
CEO
Headquarters
Hanover
FAQ – frequently asked questions
The duration of a phytotherapeutic study varies depending on the complexity, indication and regulatory requirements. Typically, the entire process from planning to the final report can take between 12 and 36 months. We will create a project-specific timeline for your project.
Yes, we accompany the entire process from study planning to approval. Our experts provide support in the preparation of meaningful study reports and in communicating with regulatory authorities.
You benefit from our specialization in the field of phytotherapy:
- Customized solutions for your product and project-specific requirements
- Comprehensive expertise in all aspects of phytotherapeutic research
- Efficient study planning and implementation
Contact us for a no-obligation consultation on your project. Our experienced team is at your disposal to develop customized solutions for your specific requirements. Together, we will successfully bring your phytotherapeutic medicinal product to market.