CLINICAL RESEARCH SERVICES TAILORED TO YOUR NEEDS
CRO AND FULL-SERVICE PROVIDER
If you are looking for a reliable CRO who can run your entire clinical research project from protocol design to publication of results, our experience and established networks will get you there.
Or maybe you need help with a specific part of the project, such as rapid patient recruitment. Simply select the project aspects you require, and we’ll tailor a program to suit your needs.
Regardless of which approach you choose, we’ll provide a single point of contact for the whole project, ensuring cohesion and clarity.
- FULLY CUSTOMIZABLE APPROACH
- CHOOSE FULL SERVICE OR SELECT PROJECT TYPES
- FROM PROTOCOL DESIGN TO PUBLICATION
Our extensive knowhow and experience across the full realm of clinical research projects includes:
trial protocols, medical device investigation plans, clinical study reports
feasibility, recruitment strategy, contracting, securing a supply chain
A CLINICAL TRIAL
securing a clinical trial contract with the institution and investigator
regulatory authority (RA) / ethics committee (EC) negotiations and submissions, consultancies
on/offsite, site management, safety monitoring
endpoints consultancy, power analysis, data management and statistical evaluations
GET FIRST DATA WITH AN EARLY
Partner with Pharmnet to generate accurate Phase I data and progress quickly and confidently to clinical proof of concept.
We develop strategies that reduce the time to key go/no-go decisions while also looking ahead to avoid potential challenges in future phases. We’ll also maximize secondary and exploratory endpoints; generating as much data as possible to save time and costs in Phase II.
Pharmnet combines intelligent protocol design with rapid start up, quality pharmacokinetic/bioequivalence studies, and an experienced team to enable smart commercialization decisions.
- generate maximum data, fast
- QUICKLY PROGRESS TO GO/NO-GO DECISIONS
- MAKE GOOD COMMERCIAL DECISIONS WITH CONFIDENCE
- FULLY COMPLIANT PROTOCOL DESIGN
- TAKE STEPS NOW TO AVOID ISSUES LATER
EFFICIENT PROTOCOL DESIGN
AND REGULATORY APPROVAL
Whether you already have a study protocol or need one to be designed, we can develop it for you and put it to the test to avoid expensive delays down the line.
With extensive knowledge of the regulatory environment, we ensure protocols are fully compliant and will handle submission to the relevant regulatory authority. Our protocols covering phase I-IV trials and medical device investigations (including first-in-human) have proven successful and receive minimal comments from regulatory authorities.
PEDIATRIC POPULATION DATA
Around 15% of the clinical trials conducted at Pharmnet are pediatric studies. From our rich experience, we can guide you through the unique ethical and regulatory requirements that exist to protect vulnerable populations, such as children.
Regulatory authority guidelines demand age-appropriate formulations and safety monitoring. Communications must be tailored to provide age-appropriate information. In addition, pediatric trials may require different endpoints, assessment tools, and study designs than adult trials.
We design and execute trials that are safe, ethical, and compliant with regulatory guidelines.
- SMOOTH NAVIGATION OF PEDIATRIC TRIAL CHALLENGES
- MEET THE HIGHEST ETHICAL AND REGULATORY STANDARDS
- RAPID PATIENT RECRUITMENT
- KNOWLEDGE OF COUNTRIES AND SITES THAT WILL YIELD THE NECESSARY PATIENT POOL
- EXCELLENT NETWORK OF CLINICIANS AND KEY OPINION LEADERS
BOOST YOUR PATIENT RECRUITMENT
Combining expert knowledge with flexibility and creative thinking, Pharmnet can help solve your recruitment challenges. Having conducted more than 450 clinical research projects, we know which countries will best suit your recruitment needs. We use our local knowledge to quickly identify suitable sites ensuring the patient pool is sufficient for your trial.
We have worked across the CEE region for the last three decades so we know the key opinion leaders who can input to projects. Our wide network of contacts also means we can easily approach and engage key trial sites.
As a full-service CRO, we understand all aspects of the process so we can identify the less obvious characteristics of a study that could impact on patient recruitment.
Our experienced team can develop a range of documents for you including:
- Clinical trial protocols and medical device investigation plans
- Clinical study reports
- SmPC and PIL reviews
- Journal papers
- Scientific conference presentations
Pharmnet’s medical writers draw on their years of working in biomedical R&D to ask the right questions in the documents and understand fully what the data shows.
- EFFICIENT TRIAL DESIGNS
- HIGH QUALITY REPORTS, REVIEWS AND PAPERS
- EXPERTS IN SPECIFIC REQUIREMENTS OF MDIs
- OVERCOME RECRUITMENT CHALLENGES OF SMALLER PATIENT POOL
MEDICAL DEVICE INVESTIGATIONS
Not all medical devices require clinical trials, but for those that do, Pharmnet will work with you to establish and perform medical device investigations (MDIs) that evaluate the performance and safety of your medical devices.
MDIs differ from drug trials in terms of format and requirements. Our experienced team can ensure your investigation runs smoothly and efficiently.
GOOD CLINICAL PRACTICE (GCP)
GCP is the international ethical, scientific and practical standard to which all clinical research is conducted. Everyone involved in research must be trained or appropriately experienced to perform the specific tasks they are being asked to undertake. Pharmnet provides auditing and training to ensure all stakeholders meet the required standard.
- EXPERIENCED AUDITORS ENSURE GCP COMPLIANCE
- CUSTOMIZED TRAINING PACKAGES AVAILABLE ACROSS WIDE THERAPEUTIC AREAS
Pharmnet auditors have decades of clinical research and quality management experience across a range of therapeutic areas. They perform site, vendor, office and system audits in the following countries: Czech Republic, Russia, Ukraine, Poland, Slovakia, Estonia, Latvia, Georgia, Bulgaria and Romania.
Leverage the knowledge and experience of the Pharmnet team with one of our tailor-made training programs. With a strong background in quality management and quality control positions within leading pharma companies, our lecturers can educate on a range of clinical research topics as well as certain therapeutic areas.