Big-pharmaceuticalisation: Clinical trials and Contract Research Organisations in India. by Sariola, S, Ravindran, D, Kumar, A, Jeffery, R

“…Using conceptual frameworks of pharmaceuticalisation and innovation, this paper analyses data from research conducted in 2010-2012 and describes how Contract Research Organisations (CROs) enable outsourcing of randomised control trials to India. …”

Register of consulting scientists: contract research organisations and other scientific and technical services /

Аудит клинического исследования

“…Большинство фармацевтических компаний и контрактно-исследовательских организаций (Contract Research Organisation - CRO) имеют в своем составе отдел по контролю за качеством проведения клинических исследований (отдел гарантии качества (Quality Assurance (QA) Department), одной из обязанностей сотрудников таких отделов и является проведение аудитов клинических исследований.…”
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Sponsors’ participation in conduct and reporting of industry trials: a descriptive study by Lundh Andreas, Krogsbøll Lasse T, Gøtzsche Peter C

“…Entry of data into the study database was done independently by academic authors without the involvement of the sponsor or a contract research organisation in one of the 69 trials. Two trials had independent data analysis and one independent reporting of results. …”
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Bioequivalence study of low dose drospirenone/ethinyl estradiol 3 mg/0.03 mg film tablets under fasting conditions in Turkish healthy female subjects by Ahmet Inal, Zafer Sezer, Berna Uluözlü, Melih Oflas, Martin Reinsch, Wolfgang Martin, Mümtaz M. Mazicioglu, Selma Alime Koru

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Strategic establishment of an International Pharmacology Specialty Laboratory in a resource-limited setting by Takudzwa J. Mtisi, Charles Maponga, Tsitsi G. Monera-Penduka, Tinashe Mudzviti, Dexter Chagwena, Faithful Makita-Chingombe, Robin DiFranchesco, Gene D. Morse

“…Results: Two high performance liquid chromatography instruments were donated by an instrument manufacturer and a contract research organisation. Laboratory space was acquired through association with the Zimbabwe national drug regulatory authority. …”
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Urinary Metabolic Distinction of Niemann–Pick Class 1 Disease through the Use of Subgroup Discovery by Cristóbal J. Carmona, Manuel German-Morales, David Elizondo, Victor Ruiz-Rodado, Martin Grootveld

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Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE) by Gryaznov, D, von Niederhäusern, B, Speich, B, Kasenda, B, Ojeda-Ruiz, E, Blümle, A, Schandelmaier, S, Mertz, D, Odutayo, A, Tomonaga, Y, Amstutz, A, Pauli-Magnus, C, Gloy, V, Lohner, S, Bischoff, K, Wollmann, K, Rehner, L, Meerpohl, JJ, Nordmann, A, Klatte, K, Ghosh, N, Taji Heravi, A, Wong, J, Chow, N, Hong, P, McCord-De Iaco, KA, Sricharoenchai, S, Busse, JW, Agarwal, A, Saccilotto, R, Schwenkglenks, M, Moffa, G, Hemkens, L, Hopewell, S, Von Elm, E, Briel, M

“…The following trial characteristics were independently associated with lower adherence to SPIRIT: single-centre trial, no support from a clinical trials unit or contract research organisation, and investigator-sponsorship.</p> <p><strong>Conclusions</strong> In 2012, industry-sponsored RCT protocols were reported more comprehensively than investigator-sponsored protocols. …”

Biopharmaceuticals protection, cure and the real winner by Mohd Lila, Mohd Azmi

“…The advancement of biopharmaceutical industry also stimulates “fringe industries” that supports the entire value chain, for example an improved bio-process technology, chromatography, bio-assay development, preclinical and clinical trials contract research organisation (CRO), sophisticated manufacturing technology, bioinformatics, contract manufacturing organisation (CMO), cold-chain management and logistics. …”
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TOFA-PREDICT study protocol: a stratification trial to determine key immunological factors predicting tofacitinib efficacy and drug-free remission in psoriatic arthritis (PsA) by Paco M J Welsing, Floris P J G Lafeber, Pim A de Jong, Janneke Tekstra, Marloes W Heijstek, Julia Spierings, Nienke J Kleinrensink, Wouter Foppen, Emmerik F A Leijten, Sarita A Y Hartgring, Mylène P Jansen, Juliëtte N Pouw, Frank T Perton, Nanette L A Vincken, Saeed Arbabi

“…The study’s progress is monitored by Julius Clinical, a science-driven contract research organisation.Trial registration number EudraCT: 2017-003900-28.…”
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Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE) by Matthias Briel, Sally Hopewell, Arnav Agarwal, Joerg J Meerpohl, Jason W Busse, Patrick Hong, Matthias Schwenkglenks, Szimonetta Lohner, Benjamin Speich, Viktoria Gloy, Erik von Elm, Sirintip Sricharoenchai, Benjamin Kasenda, Stefan Schandelmaier, Dominik Mertz, Anette Blümle, Jacqueline Wong, Alain Amstutz, Belinda Von Niederhäusern, Alain Nordmann, Giusi Moffa, Dmitry Gryaznov, Elena Ojeda-Ruiz, Ayodele Odutayo, Yuki Tomonaga, Christiane Pauli-Magnus, Karin Bischoff, Katharina Wollmann, Laura Rehner, Katharina Klatte, Nilabh Ghosh, Ala Taji Heravi, Ngai Chow, Kimberly A McCord - De Iaco, Ramon Saccilotto, Lars Hemkens

“…The following trial characteristics were independently associated with lower adherence to SPIRIT: single-centre trial, no support from a clinical trials unit or contract research organisation, and investigator-sponsorship.Conclusions In 2012, industry-sponsored RCT protocols were reported more comprehensively than investigator-sponsored protocols. …”
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Operational Differences between Product Development Partnership, Pharmaceutical Industry, and Investigator Initiated Clinical Trials by Eric I Nebie, Peter van Eeuwijk, Hélène N. Sawadogo, Elisabeth Reus, Jürg Utzinger, Christian Burri

“…We conducted an exploratory mixed-methods study with stakeholders, including clinical trial sponsors, contract research organisations, and investigators. The qualitative component included 40 semi-structured interviews, document reviews of 12 studies and observations through work shadowing in research institutions in Burkina Faso, Mali, and Switzerland. …”
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Opportunities and challenges for decentralised clinical trials in sub-Saharan Africa: a qualitative study by Juerg Utzinger, Christian Burri, Aita Signorell, Peter van Eeuwijk, Eric I Nebie, Hélène N Sawadogo, Elisabeth Reus

“…We assessed the opportunities and challenges of a digital transformation in clinical research in sub-Saharan Africa from different stakeholders’ perspectives.Methods A qualitative study, including 40 in-depth semi structured interviews, was conducted with investigators of three leading research institutions in sub-Saharan Africa and Switzerland, contract research organisations and sponsors managing clinical trials in sub-Saharan Africa. …”
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BREATHE: The Health Data Research Hub for Respiratory Health. by Chris Orton, David Ford, Aziz Sheikh, Jennifer Quint, Martin Tobin, Ian Hall, Christopher Griffiths, Jonathon Crompton, Monica Fletcher

“…With population-level data assets representing Wales, Scotland, and England and the ability to work with the Northern Ireland infrastructure housed at Swansea University, BREATHE supports 4-nation respiratory science in RWE data, and provides clinical and data linkage expertise to studies such as longitudinal cohorts, pharma companies, and contract research organisations. …”
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The development and validation of a generic instrument, QoDoS, for assessing the quality of decision making by Ronan Donelan, Stuart Walker, Sam Salek, Sam Salek

“…Methods: Semi-structured interviews about decision making were carried out with 29 senior decision makers from the pharmaceutical industry, regulatory authorities and contract research organisations. The interviews offered a qualified understanding of the subjective decision-making approach, influences, behaviors and other factors that impact such processes for individuals and organisations involved in the delivery of new medicines. …”
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A checklist for clinical trials in rare disease: obstacles and anticipatory actions—lessons learned from the FOR-DMD trial by Rebecca A. Crow, Kimberly A. Hart, Michael P. McDermott, Rabi Tawil, William B. Martens, Barbara E. Herr, Elaine McColl, Jennifer Wilkinson, Janbernd Kirschner, Wendy M. King, Michele Eagle, Mary W. Brown, Deborah Hirtz, Hanns Lochmuller, Volker Straub, Emma Ciafaloni, Perry B. Shieh, Stefan Spinty, Anne-Marie Childs, Adnan Y. Manzur, Lucia Morandi, Russell J. Butterfield, Iain Horrocks, Helen Roper, Kevin M. Flanigan, Nancy L. Kuntz, Jean K. Mah, Leslie Morrison, Basil T. Darras, Maja von der Hagen, Ulrike Schara, Ekkehard Wilichowski, Tiziana Mongini, Craig M. McDonald, Giuseppe Vita, Richard J. Barohn, Richard S. Finkel, Matthew Wicklund, Hugh J. McMillan, Imelda Hughes, Elena Pegoraro, W. Bryan Burnette, James F. Howard, Mathula Thangarajh, Craig Campbell, Robert C. Griggs, Kate Bushby, Michela Guglieri

“…Additionally, as with many academic-led studies, the FOR-DMD study did not have access to the infrastructure and expertise that a contracted research organisation could provide, organisations often employed in pharmaceutical-sponsored studies. …”
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