Ecron Acunova has developed protocols and monitored First-n-Man Studies at our facilities in India and Germany. Insight from Toxicological studies on the drug, published information on FIM (First-in-man) studies in the class of drugs, experience of Key opinion Leaders (KOLs) in reputed academic centres in the Nordic region, Netherlands, France, Singapore, Thailand and US, experience of operating our own Pharmacology units qualifies us to partner in this phase of drug development.
First-in-man studies in Europe and Canada can be conducted in either location at our alliance partner, Biotrial. The team has over 20 years experience in FIM studies. (www.biotrial.com)
We have the experience and set up to conduct/monitor dose finding and drug interaction studies.
Proof of Concept and Early Phase Studies
Ecron Acunova has in-house therapeutic specialists, access to luminary sites and, sophisticated facilities to conduct PK/PD studies on special populations. We also have experience in the use of biomarkers and imaging as end points.
Proof of concept studies enable our clients to be better prepared and avoid any late phase loopholes that can impact costs. These studies are conducted across several therapeutic areas. We have our own central lab, bio-analytical lab and experience in imaging. Familiarity with early phase tools and techniques specific to indications like Oncology, Respiratory, Dermatology and Infection makes EA a useful partner in this phase.
Phase III and Registration Studies
We have extensive experience in conducting global Phase III studies with our own FTEs in 19 European, 8 Asian countries and US/Canada for registration in the key markets of Europe, Asia and America. We have conducted studies for pharma, biotech, medical device, generic and nutrition companies. We can add additional countries of interest using our qualified and tested partners.
Peri-Approval Studies (PAS)
Ecron Acunova shapes PAS studies to the needs of late stage research and performs large national/ multinational scale studies with innovative designs.
We especially support clients with strategies and processes for Phase III. In these studies, end-to-end needs of the clients involved in Phase III are addressed. These include protocol design, enrolment of unique patient populations, define relevant end points and gather information for the safety of products, its cost effectiveness and test of the product in a ‘real world scenario’.
Through such studies we are able to thoroughly check issues that arise in late stage research relating to diverse regulatory needs, effective site management, and client needs.
Our team has experience in conducting disease registries in the following therapeutic indications; Acute Myocardial Infarction, Diabetes and Hypertension.
We have done both Clinic-Based Registry as well as Population-Based Registry.
Post Approval Safety Studies (PASS)
Post-Marketing Surveillance Studies (Post-Authorization Safety Studies) are defined and settled by the Notice to Applicants NTA III/5944/94. These regulations, together with various publications open a wide range for the conduct, not so much in the regulatory area but in the quality of planning and performance of such studies.
We strive to adopt quality rules and procedures of research to ensure smooth progress without ignoring marketing needs and goals. As clients, you may opt for a full scope of services ranging from planning to reporting/ publication or for only partial services. In partial services, the field phase of the PMS/PASS may be conducted by the sponsor's own sales representatives with Ecron Acunova acting in the background, or sites may be selected, contacted and monitored by the Ecron Acunova staff.
In the scenario where regulators have asked a group of marketing authorization holders to jointly conduct a PASS study, EA has played the role of sponsor in such a study.
Post-Marketing Surveillance (PMS)
Considering the orphan drug nature, or public health advantage in approval of a drug, Regulators grant conditional approval for marketing, subject to post marketing surveillance. We have experience in conducting this type of study.
In PMS Services, we create value by providing:
- Marketing-experienced consultants and sales professionals to assist in the planning of your projects
- Quality standards that are based on our experience in clinical research
- Detailed verification by a physician in every case
Investigator initiated studies
Often KOLs and reputed academic sites are asked by sponsors and Physician societies to scientifically, clinically, and statistically validate certain commonly held notions on marketed drugs. For example, this could be a widespread ‘off-label’ use of an approved drug in an alternate indication. These could be interventional or non-interventional (observational) studies. For example, this could be a widespread ‘off-label’ use of an approved drug in an alternate indication.
We have experience in conducting several such studies.
Ecron Acunova has taken over responsibility for a considerable number of projects which had been initiated by other CROs elsewhere but did not meet client expectations. We offer:
- Immediate rescue model set-up
- Intensive measures adequately chosen to push your project
- Large investigator pool to speed up recruitment
- Competent contact with investigators
- Relocation of trial to countries with known high recruitment rates, such as Central Eastern Europe and Asia
- Take-over of data management, statistical analysis, or medical writing