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Author(s):  
Sharon V Medendorp ◽  
Allison Crumpler

Effective management of a clinical trialrequires having real time access to information that provides useful insightsinto trial progress and that lends itself to collaborative decisionmaking.  Data visualizations using datafrom multiple source systems employed during the conduct of a clinical trialhave become an essential tool in the recent past as support for collaborativedecision making by project teams. Having the ability to access, analyze, read,work with, and present data to support an argument are  important skills that ensure datavisualizations fulfill their purpose in clinical trial management. There is anexpectation that members of the clinical trial team either possess or developthe data literacy skill sets necessary to collaborate on the successfulexecution of a clinical drug development trial. Here we describe thedevelopment of a Data Learning Series program targeted to increase the data literacyskills within a Contract Research Organization in support of the digitalevolution of the drug development industry.


Author(s):  
Sharad Desai ◽  
Nilesh Patel

Nowadays health agencies of regulated markets are becoming stringent regarding the bio-studies. So clinical/contract research organization (CRO) need to be selected carefully after their detailed assessment. As per requirement of bio-study CRO should be assessed with the study specific checklist of questions before awarding the bio-study. Questions related to various services of study like: Clinic phase, analytical phase, Pharmacokinetic and statistical phase, ethics approval, QA/QC, record handing etc. and related to CRO capabilities are discussed here with their relevance to conclude the abilities of CRO for successful execution of bio-study. Hence, this paper focuses all possible questions which need to be assessed before selection of CRO mainly for Bioavailability/Bioequivalence (BABE) study in healthy adult volunteers. Properly selected CRO will help for smooth execution of study and quality report and subsequently, hassle-free approval of dossier submitted to regulatory agency.


Bioanalysis ◽  
2021 ◽  
Author(s):  
Daisy Yuill ◽  
Chiara Carla Rospo ◽  
Henko Tadema ◽  
Jade Louber ◽  
Sijranke Post

As the number of therapeutic modalities expand, and the field of scientific research evolves toward finding treatment solutions for complex and rare disease, an ability to demonstrate efficacy through biomarker end points in clinical development studies is becoming increasingly important. Implementing flow cytometry in a clinical setting is challenging and many sponsor organizations take a hybrid approach, developing complex analytical methods internally before identifying and forming partnerships with contract research organizations to conduct the formal analytical method validation and sample bioanalysis. Ensuring that these interactions are effective is critical to the delivery of high-quality, impactful clinical data. This paper provides a review of the recommendations, challenges and solutions for the implementation of decision-making flow cytometry end points effectively utilizing the Sponsor Contract Research Organization interaction.


Separations ◽  
2021 ◽  
Vol 8 (10) ◽  
pp. 168
Author(s):  
Xin Chen ◽  
Patrick C. Bailey ◽  
Clarissa Yang ◽  
Bryant Hiraki ◽  
Michael J. Oldham ◽  
...  

Aerosol constituent yields have been reported from a wide range of electronic nicotine delivery systems. No comprehensive study has been published on the aerosol constituents generated from the JUUL system. Targeted analyses of 53 aerosol constituents from the four JUUL products currently on the US market (Virginia Tobacco and Menthol flavored e-liquids in both 5.0% and 3.0% nicotine concentration by weight) was performed using non-intense and intense puffing regimens. All measurements were conducted by an ISO 17025 accredited contract research organization. JUUL product aerosol constituents were compared to published values for the 3R4F research cigarette and IQOS Regular and Menthol heated tobacco products. Across the four JUUL products and two puffing regimes, only 10/53 analytes were quantifiable, including only two carbonyls (known propylene glycol or glycerol degradants). The remaining analytes were primary ingredients, nicotine degradants and water. Average analyte reductions (excluding primary ingredients and water) for all four JUUL system aerosols tested were greater than 98% lower than 3R4F mainstream smoke, and greater than 88% lower than IQOS aerosol. In summary, chemical characterization and evaluation of JUUL product aerosols demonstrates a significant reduction in toxicants when compared to mainstream cigarette smoke from 3R4F reference cigarettes or aerosols from IQOS-heated tobacco products.


2021 ◽  
Vol 16 (3) ◽  
pp. 87-91
Author(s):  
Poonam Chauhan ◽  
Monica Mendonca

The evolution of the drug development process and testing its efficacy is a primary responsibility of pharmaceutical companies. The time cost investment involved in identifying a compound suitable to its target disease and making it available to the masses eventually led to the rise of the Contract Research Organization (CRO) in the domain of clinical research.  Pharmaceutical companies outsource the research and clinical trials to CRO’s. A CRO has a vital role from drug discovery to the launch and marketing of drugs. India is emerging as attractive location for global clinical trial. It has cost advantage compared to other countries and a well-developed associated services like data management, medical writing and pharmacovigilance.  The Central Drug Standard Control Organization (CDSCO) is the National Regulatory Authority in India that aims to bring safe drugs and standardize clinical research. Pharmaceutical Companies benefit by strategically working with CRO to gain speed and efficiency in drug discovery, generation and retention of clinical data integrity. The risk associated with CRO relates to delays and inferior quality of work, thereby making CRO a critical decision for Pharmaceutical Company.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Wendy Holman ◽  
Wayne Holman ◽  
Stacy McIntosh ◽  
Wendy Painter ◽  
George Painter ◽  
...  

AbstractA recently published article described the safety, tolerability, and pharmacokinetic profile of molnupiravir (Painter et al. 2021), a novel antiviral agent with potent activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19). Here, we report an unprecedented collaboration between sponsor, contract research organization (CRO), and regulatory authorities that enabled accelerated generation of these phase I data, including administration of the first-in-human (FIH) dose of molnupiravir within 5 days of receiving regulatory approval in the United Kingdom (UK). Single and multiple ascending dose (SAD and MAD, respectively) cohorts were dosed in randomized, double-blind, and placebo-controlled fashion, with a 6:2 active-to-placebo ratio in each cohort. A food-effect (FE) cohort included 10 subjects who were randomized to receive drug in the fasted or fed state followed by the fed or fasted state to complete a fed and fasted sequence for each subject. Dose escalation decisions were accelerated and MAD cohorts were initiated prior to completion of all SAD cohorts with the provision that the total daily dose in a MAD cohort would not exceed a dose proven to be safe and well-tolerated in a SAD cohort. Dosing in healthy volunteers was completed for eight single ascending dose (SAD) cohorts, seven multiple ascending dose (MAD) cohorts, and one food-effect (FE) cohort within approximately 16 weeks of initial protocol submission to the Research Ethics Committee (REC) and Medicines and Healthcare products Regulatory Agency (MHRA). Working to standard industry timelines, the FIH study would have taken approximately 46 weeks to complete and 33 weeks to enable phase 2 dosing. Data from this study supported submission of a phase 2/3 clinical trial protocol to the US Food and Drug Administration (FDA) within 8 weeks of initial protocol submission, with FDA comments permitting phase 2 study initiation within two additional weeks. In the setting of a global pandemic, this model of collaboration allows for accelerated generation of clinical data compared to standard processes, without compromising safety.


2021 ◽  
Vol 07 (01) ◽  
Author(s):  
Cyntia Wulandari ◽  
◽  
Maharani Maharani ◽  
T Djoharsjah

Abstrak: Penelitian ini bertujuan untuk mengetahui nilai kesiapan aspek internal. Penelitian ini adalah penelitian nonhipotesa dengan pendekatan kuantitatif. Populasi penelitian ini adalah seluruh staf pada divisi R&D PT Bio Farma. Sampel dipilih menggunakan random sampling method. Data yang digunakan adalah data primer yang dikumpulkan melalui kuesioner. Teknik interpretasi aspek penilaian dilakukan dengan kategorisasi terhadap skor tanggapan responden. Hasil penelitian menunjukan bahwa pada aspek pasar dengan nilai persentase 80,25% termasuk dalam kategori mampu, pada aspek sumber daya manusia mempunyai persentase 82,31% termasuk dalam kategori lebih dari mampu dan aspek teknik dan teknologi menunjukan nilai persentase 80% dengan kategori mampu. Hasil penelitian ini dapat menjadi acuan dasar dalam analisis studi kelayakan yang selanjutnya dapat dilakukan dalam pengembangan CRO pada divisi R&D PT Bio Farma. Selanjutnya juga dapat menjadi tambahan informasi pada analisis aspek eksternal dan perumusan perencanaan strategi bisnis bagi CRO tersebut. Abstract: This study aims to determine the value of internal aspects of readiness. This research is a non-hypothetical research with a quantitative approach. The population of this study were all staff in the R&D division of PT. Bio Farma. The sample was selected using a random sampling method. The data used is primary data collected through a questionnaire. The technique of interpreting the assessment aspect is done by categorizing the respondent's response scores. The results showed that the market aspect with a percentage value of 80.25% was included in the capable category, in the human resources aspect it had a percentage of 82.31% included in the more than capable category and technical and technological aspects showed a percentage value of 80% with the capable category. The results of this study can be used as a basic reference in the analysis of feasibility studies which can then be carried out in the development of CRO at the R&D division of PT Bio Farma. Furthermore, it can also be additional information on the analysis of external aspects and the formulation of business strategy planning for the CRO.


2021 ◽  
pp. 019262332110170
Author(s):  
Matt Jacobsen ◽  
Arthur Lewis ◽  
James Baily ◽  
Alain Fraser ◽  
Dan Rudmann ◽  
...  

The approach undertaken to deliver a Good Laboratory Practice (GLP) validation of whole slide images (WSIs) and the associated workflow for the digital primary evaluation and peer review of a GLP-compliant rodent inhalation toxicity study is described. The contract research organization (CRO) undertook validation of the slide scanner, scanner software, and associated database software. This provided a GLP validated environment within the database software for the primary histopathologic evaluation using WSI and viewed with the database software web viewer. The CRO also validated a cloud-based digital pathology platform that supported the upload and transfer of WSI and metadata to a cache within the sponsor's local area network. The sponsor undertook a separate GLP validation of the same cloud-based digital pathology platform to cover the download and review of the WSI. The establishment of a fit-for-purpose GLP-compliant workflow for WSI and successful deployment for the digital primary evaluation and peer review of a large GLP toxicology study enabled flexibility in accelerated global working and potential future reuse of digitized data for advanced artificial intelligence and machine learning image analysis.


2021 ◽  
Author(s):  
Oren Cohen ◽  
Wendy Holman ◽  
Wayne Holman ◽  
Wendy Painter ◽  
Stacy McIntosh ◽  
...  

Abstract A recently published article described the safety, tolerability and pharmacokinetic profile of molnupiravir, a novel antiviral agent with potent activity against SARS-CoV-2, the causative agent of COVID-19. Here, we report an unprecedented collaboration between sponsor, contract research organization (CRO) and regulatory authorities that enabled accelerated generation of these phase I data, including administration of the first-in-human (FIH) dose of molnupiravir within 5 days of receiving approval from the Research Ethics Committee (REC) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK). Frequent, direct communication with regulatory authorities and parallel, streamlined sponsor-CRO working groups facilitated this accelerated timeline. Dosing in healthy volunteers was completed for eight single ascending dose (SAD) cohorts, seven multiple ascending dose (MAD) cohorts, and one food-effect (FE) cohort within approximately 16 weeks of initial protocol submission to the REC and MHRA. Working to standard industry timelines, the FIH study would have normally taken approximately 46 weeks to complete and 33 weeks to enable Phase 2 dosing. Data from this study supported submission of a Phase 2/3 clinical trial protocol to the US Food and Drug Administration (FDA) within eight weeks of initial protocol submission, with FDA comments permitting phase 2 study initiation within two additional weeks. In the setting of a global pandemic, this model of collaboration allows for accelerated generation of clinical data compared to standard processes, without compromising safety.


Bioanalysis ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 199-201
Author(s):  
Fan Jin ◽  
Daniel Tang ◽  
Kelly Dong ◽  
Dafang Zhong

This article provides an update on new development of China Bioanalysis Forum (CBF). CBF became a member association of Chinese Pharmaceutical Association (CPA) at the end of 2019. The official ceremony and first scientific symposium were held in Shanghai on 18 September 2020. The president of Chinese Pharmaceutical Association and representatives from industry, Contract Research Organization (CRO), hospitals and academic institutes attended the ceremony. Seven experts in the field gave presentations on various topics including Drug Metabolism and Pharmacokinetics (DMPK) and bioanalytical support in drug discovery and development as well as experience in Traditional Chinese Medicine research. With the continuous growth of research and development in China, it is well acknowledged that bioanalysis provides critical support for new innovative medicines and generic drug development in the region.


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