ECRON ACUNOVA, a full service CRO, with over 2 decades track record, provides end-to-end services for Phase I - IV clinical research including Clinical Trial Management, Clinical Data Management, PK/PD services and Central Lab. ECRON ACUNOVA has research facilities in India as well as an established presence in various parts of Europe and in United States. As regional experts, we operate each Region as a priority market with a European HQ at Frankfurt, United States HQ at Princeton and Asian HQ at Bangalore
We offer clinical development services to pharmaceutical, biotechnology and medical diagnostics industry. Our service quality, therapeutic expertise and global reach have allowed us to grow rapidly, building a list of demanding clients. We provide an attractive package of services coupled with the ability to rapidly conduct clinical trials utilizing a world class delivery platform. Our long company history, wide geographic presence and extensive patient access, regulatory credibility and quality standards as well as cultural diversity and capabilities of our team enhance our client benefits.
ECRON ACUNOVA creates value by:
- Delivering quality on time within budget with personalized services, through an intelligent combination of capabilities and resources.
- Knowledge based on 21 years experience in clinical research with established presence in different parts of Europe, Asia and America facilitating deep regional knowledge.
Highlights:
- Expertise to conduct Phase I-IV research for Pharma, Biotech, Phyto and Device sponsors.
- Enhanced control over Study Management as a Full Service CRO – from protocol to study report.
- Faster enrolment with access to a large patient pool matching demographics of large markets. For example, we have preferred access to 19 teaching hospitals of Manipal University -Asia's largest academic medical centre treating 1.5 mn patients with more than 1500 physicians. With privileged access, we are able to provide to site, SMO services to improve the research productivity of Investigators.
- We have experience in conducting studies with imaging and biomarker end points. Our Central lab has molecular diagnostic capability giving pharmaco-genomic insight. We are equipped to work with e-CRF and can prepare e-CTD. These help in early availability of CSR.
- Our direct presence in emerging geographies like India and East Europe gives access to patients and talent, making our service cost competitive.
- Quality is built into our service delivery. Our operations are ISO compliant, research sites are ICH GCP compliant, data management is 21CFR Part 11 compliant and Central Labs are CAP and ISO certified.
- US FDA and WHO have audited Phase I studies conducted by us. A number of sponsors have audited our operations with no major observations. Our studies have been audited by regulators including US FDA and investigational products have received marketing approval.
- High credibility established with European, US and Indian regulators namely FDA, EMEA, BfArM, and DCGI amongst others.
- Personalized services and flexibility provided with 265 full time professionals, amongst which 47 are MD’s and Ph D’s. We have turned the diversity of cultures into synergistic advantages
Vision
Become Global Benchmark of Excellence in CRO Services Enhancing Life
Mission
As an Expert CRO Deliver High Quality Faster, at Competitive Cost with Personalized Service
Regulatory Affairs
Our regulatory consultant group is experienced in the development of positioning strategies, integrated planning, management and submission of study related documents to regulatory authorities and ethics committees.
ECRON ACUNOVA’s regulatory experts are experienced in effective and diplomatic liaison with regulatory bodies in support of a wide variety of indications and represent/support you in meetings with regulatory agencies.
PK/PD Studies
Equipped with advanced infrastructure, we conduct PK/PD studies with healthy volunteers for the generic industry comprising three clinical units with 150 beds located in Specialty Hospitals. Recorded as the largest study was a 120 volunteer study conducted till date. An independent Central Ethics Committee reviews the study. Volunteers screening tests are done in our CAP certified lab. A library of validated methods is available in several indications. A sophisticated analytical lab analyses the samples in a wide range of matrices on a bank of HPLC, LCMS/MS. Pivotal Studies have been conducted for submission to Health Canada, EU, DCGI, MHRA,….USFDA, WHO. Studies have been audited by regulators including US FDA and WHO.
First in Man Studies
A 6 bed ICU is available to conduct first-in-man, dose escalation and drug interaction studies.
Proof of Concept and Early Phase Studies
In house therapeutic specialists, access to luminary sites, sophisticated facilities to conduct PK/PD studies on special population and patients with experience in use of biomarker and imaging as end points. This establishes us as adequately suitable for conducting proof of concept studies. In addition, with capability and experience in early phase II studies, we have been able to attract many sponsors to do such studies.
Rescue Studies
ECRON ACUNOVA has taken over responsibility for a considerable number of projects which had been started elsewhere and which have not met client’s expectations. ECRON ACUNOVA specifically offers:
- immediate set-up of rescue model
- intensive measures adequately chosen to push your project
- large investigator pool to speed up recruitment
- competent contact with investigators to assist you to understand the protocol
- shifting of trial in countries with known high recruitment rates.
Phase III and Registration Studies
We have extensive experience in conducting global Phase III studies in our geography and Phase IV studies for registration in specific countries. Currently we are engaged in conducting over 50 such trials.
Peri-Approval Studies
ECRON ACUNOVA shapes PAS studies to the needs of late stage research and performs national/multinational large scale studies with appropriate design.
Clinical Trial Supply Management
To overcome the logistic and supply chain hurdles to get investigational products to study sites, we offer in house services to import, custom clear, store, supply to site and randomize. We oversee drug accountability and arrange return or destruction of samples at the end of the study.
Clinical Operations
Our CRA’s attend in-house education courses and are updated with latest literature on developments in the industry. ECRON ACUNOVA performs annual ICH GCP exams to ensure highest working standards. Project teams are trained for each study in advance with regard to the study’s medical background, its goals, hurdles handling and its organization, to make the whole team familiar with the study and to find out necessary organizational adjustments. Project manager or CRA supervisors perform site-by-site visits with monitors during the initial phase as well as throughout the study. They discuss site-specific findings as well as conditions and lay down guidelines on what and how to follow-up consistently.
Project Management
Outsourcing of project management to ECRON ACUNOVA means highly dedicated interdisciplinary team steered by one project expert who is the key driver for client contacts throughout the project. We have an outstanding record of continuity in project management teams which is found very useful by sponsor’s study team.
Central Lab Testing Service
We offer a CAP certified central testing lab service to support clinical trials. Test design, report design, kit design, kit supply to study sites, site setup, briefing at investigator meetings, project management, site feedback, lab data integration to trial data base, sample archival …are all part of our end to end service offering. ECRON ACUNOVA’s Central Lab at Bangalore has inter lab compatibility with LKF, a central lab based in Germany. We can provide harmonized service in Europe and Asia. Our lab has molecular diagnostic capabilities including biomarker validation capability.
Clinical Data Management
ECRON ACUNOVA provides state-of-the-art data management of clinical studies with respect to both, procedures and equipment. The variety of services ranges from traditional paper-based workflow to modern remote data capture are fully compliant with 21 CFR part 11 regulations. Detailed SOP’s describe content, re¬sponsibilities as well as procedure and quality measures for all tasks.
Oracle Clinical was introduced in the company in the year 2000. Currently the organisation uses OPA 4.5 (Oracle Pharmaceutical Applications), encompassing Oracle Clinical 4.5, TMS 4.5 (Thesaurus Management System), and RDC (Remote Data Capture). Electronic CRF as well as paper CRF can be designed and derived di¬rectly within the system allowing conventional study conduct, purely electronic data management as well as hybrid solutions. SAS version 8.2 (Statistical Analysis System) is used for data export from Oracle Clinical to the statistical analysis and to the sponsor.
Medical Writing
Our in-house medical writers are involved in the study through every stage to ensure a comprehensive understanding of the study. Delivery of your final, summarized data will be presented in paper copy as well as password-protected electronic files.
Biostatistics
ECRON ACUNOVA provides continuous biometric advice during the study: biometric study planning, sample size calculation, randomization procedures, analysis plan, interim analysis, valid statement (classification of patients into different populations for analysis), blinded review committee, bio-statistical evaluation with SAS™, statistical report.
Pharmacovigilance
Our team consist of dedicated, skilled, and experienced physicians, life science professionals, and other experienced clinical professionals in drug safety. Our services encompass safety management, regulatory reporting, post-marketing surveillance as well as technology support.
For further information, please visit: www.ecronacunova.com
India
Mobius Towers, SJR i-Park
EPIP, Whitefield
Bangalore – 560066
India
T: +91 80 66915700
Da.prasanna@ecronacunova.co
m
Europe
Hahnstrasse 70
D 60528 Frankfurt,
Germany
T: +49 69 6680300
antal.hajos@ecronacunova.com
United States
502 Carnegie Center
Suite 100, Princeton,
NJ, 08540
T: +1 973 396 2742
Kohkan.shamsi@ecronacunov
a.com
