Post-Marketing Surveillance (PMS)

Post-Marketing Surveillance Studies (Post-Authorization Safety Studies) are defined and settled by the Notice to Applicants NTA III/5944/94. These few 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.

At Ecron Acunova 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 our full scope of services in this area, ranging from planning to reporting/ publication or for a partial service.

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 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 on every case

Rescue 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 (CEE) and India

Successful interventions by us through rescue studies (click to expand).

First-in-man Studies

Ecron Acunova has well equipped pharmacology units in India, backed by ICU and excellent emergency management set up to conduct first-in-man, dose escalation and drug interaction studies. First-in-man studies for sponsors outside of India can also be conducted by a team with two decades of experience at our alliance partner BiotriaL, France. (www.biotrial.com).

Proof of Concept and Early Phase Studies

Ecron Acunova has in-house therapeutic specialists, access to luminary sites, sophisticated facilities to conduct PK/PD studies on special populations and patients and experience in use of biomarkers and imaging as end points. The proof of concept studies will enable our clients to be better prepared and avoid any late phase loopholes that can impact costs. These studies are conducted across therapeutic areas.

Phase III and Registration Studies

We have extensive experience in conducting global Phase III studies in 19 European & 7 Asian countries for registration in key markets of Europe, Asia and America.

Peri-Approval Studies (PAS)

Ecron Acunova shapes PAS studies to the needs of late stage research and performs national/multinational large 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 taken care of; these include the design of protocols, reach out to the unique population, 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, amongst others.

We are shaping the study to the needs of late stage research.