“Accelsiors CRO is happy to announce the successful completion of a Phase III Clinical Trial in oncology, on a biosimilar compound. Thanks to the Team who worked on this complex study, we were able to wrap up all of our activities, starting from a very challenging set-up phase all the way to the data base lock in less than 2 years,” said Mihaly Juhasz, Chief Executive Officer of Accelsiors CRO.

“This was one of the most challenging projects Accelsiors CRO had worked on,” said Desislava Simeonova MD, Head of Clinical Operations at Accelsiors CRO. “This is one more reason for us to be happy with the high quality of work our Team was able to demonstrate during the whole course of the study. We had 10 countries on board, a high number of sites per country and some challenging subject eligibility criteria which had to be followed. Despite of all of these challenges that we encountered along the way, Accelsiors CRO has shown a significant level of experience and expertise in this field, allowing us to successfully make our way towards achieving the mission of this project. I would like to thank the whole team once again for their dedication and for the quality of work shown on this project, and I look forward to working with all of them again on Accelsiors’ new projects in oncology.”

Accelsiors CRO & Consultancy Services Ltd. is a midsized full service European Contract Research Organization, a provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. By combining our unique experience and expertise as well as our comprehensive capabilities across all areas of clinical drug development, we assist our clients to become successful drug developers. We have the operational flexibility to provide development services that perfectly match the demands of each of our clients, as part of an integrated “full service” solution. We specialize in the strategic planning, development, management and analysis of programs that support Clinical Development – from Phase I to marketing authorization and beyond.

Accelsiors is a synonym for Acceleration, Excellence & Achievements in clinical drug development. Every effort is made within Accelsiors to truly understand, accurately determine, clearly and consistently communicate and continuously satisfy the requirements of our clients in a manner which is efficient and effective to them whilst providing Accelsiors with the opportunity to grow and excel.

For further information please contact Accelsiors Communication Manager, Mr. Ferenc Erdos at F.Erdos@accelsiors.com.

“After very positive feedback gained during the Phase Ib/IIa study, Accelsiors CRO is proud to announce the start of set-up and regulatory procedures for the subsequent Phase II Clinical Trial with the promising innovative compound used for the treatment of Hepatitis C,” said Desislava Simeonova MD, Head of Clinical Operations at Accelsiors CRO.

“This project brings together a group of companies with strong expertise and experience in Hepatitis C treatment,” said Emil Jakovljevic, Director, Study Set-up and Regulatory Compliance at Accelsiors CRO. “Accelsiors CRO, together with our partners on this project, is excited to work on the development path of such a promising compound for Hepatitis C treatment. Encouraged by the interim results of the Phase Ib/IIa study, we are looking forward with great expectations to the Phase II study we are currently preparing. We are also delighted to say that all of the investigators who are taking part in the currently still ongoing Phase Ib/IIa study showed high interest to continue their participation in the upcoming study phase. This is one additional indicator of the potentials this compound is showing and a clear sign of the needs for further innovative approaches in Hepatitis C treatment.”

Accelsiors CRO & Consultancy Services Ltd. is a midsized full service European Contract Research Organization, a provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. By combining our unique experience and expertise as well as our comprehensive capabilities across all areas of clinical drug development, we assist our clients to become successful drug developers. We have the operational flexibility to provide development services that perfectly match the demands of each of our clients, as part of an integrated “full service” solution. We specialize in the strategic planning, development, management and analysis of programs that support Clinical Development – from Phase I to marketing authorization and beyond.

Accelsiors is a synonym for Acceleration, Excellence & Achievements in clinical drug development. Every effort is made within Accelsiors to truly understand, accurately determine, clearly and consistently communicate and continuously satisfy the requirements of our clients in a manner which is efficient and effective to them whilst providing Accelsiors with the opportunity to grow and excel.

For further information please contact Accelsiors Communication Manager, Mr. Ferenc Erdos at F.Erdos@accelsiors.com.

Accelsiors CRO announce first regulatory clearance for the Phase II Clinical Trial with long-acting Human Growth Hormone.

“After all of the Clinical Trial Applications performed, Accelsiors CRO is pleased to announce the grant of the first full regulatory clearance for the Phase II Clinical Trial with long-acting Human Growth Hormone,” said Bojana Gacesa, Director, Regulatory Affairs at Accelsiors CRO.

“The study is planned to be conducted at 12 sites across 6 countries,” said Emil Jakovljevic, Director, Study Set-up and Regulatory Compliance at Accelsiors CRO, “and is expected to open new horizons in the development and utilization of long-acting hGH products. With the first full study approval onboard, we are able to enter the next phase of our start-up activities, which should result in the first screened patient in the very close future. We are very excited to be a part of this extremely promising development program, and would also like to thank all of our investigators involved in this project, on the interest and enthusiasm shown throughout the study start-up phase.”

Accelsiors CRO & Consultancy Services Ltd. is a midsized full service European Contract Research Organization, a provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. By combining our unique experience and expertise as well as our comprehensive capabilities across all areas of clinical drug development, we assist our clients to become successful drug developers. We have the operational flexibility to provide development services that perfectly match the demands of each of our clients, as part of an integrated “full service” solution. We specialize in the strategic planning, development, management and analysis of programs that support Clinical Development – from Phase I to marketing authorization and beyond.

Accelsiors is a synonym for Acceleration, Excellence & Achievements in clinical drug development. Every effort is made within Accelsiors to truly understand, accurately determine, clearly and consistently communicate and continuously satisfy the requirements of our clients in a manner which is efficient and effective to them whilst providing Accelsiors with the opportunity to grow and excel.

For further information please contact Accelsiors Communication Manager, Mr. Ferenc Erdos at F.Erdos@accelsiors.com.

Accelsiors CRO Advances the Conversations on Out-sourcing Strategies at BIO 2010.

“We are delighted to announce we exhibited at 2010 BIO International Convention, May 3-6, 2010 in Chicago,” said Dr Vid Stanulovic, Head of Drug Safety and Medical Writing at Accelsiors CRO. “Thanks to all the contacts we had a chance to establish during the Convention, we were able to discuss a range of hot topics in the drug development industry and to open a number of serious collaboration prospects,” he added.

“This strengthens Accelsiors position as a leading CRO supporting drug development in the biopharmaceutical industry and highlights our unique focus on the specific complexities of biological products” said Dr Mihaly Juhasz, CEO at Accelsiors CRO. “Thanks to our team’s expertise in the field of specific guidelines and regulatory requirements concerning biopharmaceuticals, we are able to guide our clients from the early clinical phases to marketing authorization and beyond.”

Accelsiors CRO & Consultancy Services Ltd. is a midsized full service European Contract Research Organization, a provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. By combining our unique experience and expertise as well as our comprehensive capabilities across all areas of clinical drug development, we assist our clients to become successful drug developers. We have the operational flexibility to provide development services that perfectly match the demands of each of our clients, as part of an integrated “full service” solution. We specialize in the strategic planning, development, management and analysis of programs that support Clinical Development – from Phase I to marketing authorization and beyond.

Accelsiors is a synonym for Acceleration, Excellence & Achievements in clinical drug development. Every effort is made within Accelsiors to truly understand, accurately determine, clearly and consistently communicate and continuously satisfy the requirements of our clients in a manner which is efficient and effective to them whilst providing Accelsiors with the opportunity to grow and excel.

For further information please contact Accelsiors Communication Manager, Mr. Ferenc Erdos at F.Erdos@accelsiors.com.