Contract Research Organization Review Assignment

Individual Assignment - Contract Research Organization review
Table of Contents
TOC o 1-3 h z u Clinical Research Organizations (CROs) PAGEREF _Toc3983292 h 11.0 PRA Health Sciences PAGEREF _Toc3983293 h 11.1 Size PAGEREF _Toc3983294 h 11.2 Location PAGEREF _Toc3983295 h 21.3 Services PAGEREF _Toc3983296 h 22.0 Pharmaceutical Product Development PAGEREF _Toc3983297 h 22.1 Size PAGEREF _Toc3983298 h 22.2 Location PAGEREF _Toc3983299 h 32.3 Services PAGEREF _Toc3983300 h 33.0 Similarities between PPD and PRA PAGEREF _Toc3983301 h 34.0 Dissimilarities between PPD and PRA PAGEREF _Toc3983302 h 34.1 Pharmaceutical Product Development PAGEREF _Toc3983303 h 34.2 PRA Health Sciences PAGEREF _Toc3983304 h 55.0 Selection of the CRO PAGEREF _Toc3983305 h 6
Clinical Research Organizations (CROs)
World population today is in need of enhanced medical care. This require a huge driving force at the back of drug discoverys task to discover latest medicines.
The drug sighting process is intricate and inflexible. The medical stage, in particular, is resource rigorous, challenging andhigh risk. A very well balance is necessary to implement this stage appropriately CITATION Cra13 l 1033 (Craig J. Reist Tyrus L. Rorick Lisa G. Berdan Renato D. Lopes, 2013).
Clinical Research Organizations (CROs) support drug manufacturers on their path to find out and endorse drugs of the upcoming by captivating some of the clinical stages the burdens. Data study, project supervision, tests, trials that are run before approval, clinical and pre-clinical are just few of the activities enclosed CITATION Cra13 l 1033 (Craig J. Reist Tyrus L. Rorick Lisa G. Berdan Renato D. Lopes, 2013). This relationship, which is based on faith and ability, can honor manufacturers with discriminating proficiency as well as price and time efficiencies. These paybacks come at the cost of duties such as concentrated communication organization, privacy concerns and rigid considerations Pharmaceutical and biologics firms require to choose dependable partners who will put in value to their medical research. This is a multipart decision process linking the assessment of numerous variables.
1.0 PRA Health SciencesPRA is a research organization and has become the worlds largest CRO (Contract research organization) due its transparency and operational efficiencies. It is a health care industry based on pharmaceuticals and biotechnology. CITATION htt l 1033 (Anon., n.d.)1.1 SizeHeadquarters located in Raleigh, North Carolina. It is served worldwide in more than 85 countries and has more than 30 years of experience. It has more than 15000 employees working in 85 countries.
1.2 Location
The headquarter is located in US. It has six offices in
Shanghai, Beijing,
Guangzhou,
Wuhan
Hong Kong
It offers necessary technical support and global services to incorporate study of any scope and size.
1.3 Services
Below are the major services provided by PRA
It provides clinical diagnostics that includes comprehensive knowledge and central monitoring approach with focal point on patient outcome and sample quality.
It also provides bioanalytical laboratory which produce critical results in a given time frame which are to be examined. This efficiency makes clients to do research much faster.
Custom-built development solutions authorize companies which have restricted infrastructure to maximize our broad experience to convey modern approaches that boost development processes, streamline quality, and improve efficiency.
Safety amp risk management teams effort in a unique way with further solution areas such as therapeutic expertise and post-Marketing to assist clients in a better way and make effective management of their drug safety information.
Other services include
Clinical pharmacology
Clinical development
Clinical informatics
2.0 Pharmaceutical Product Development
PPD is a contract research organization with academic government and medical device as their clients and partners. It also has drug development laboratory and provide life cycle management services in addition.
2.1 Size
It has 92 offices in 48 countries with more than 21000 employees. Headquarter located in Wilmington United States. PPDs experienced leadership team provides decision-making leadership in the everyday management of the company.
2.2 Location
PPD has its worldwide headquarters inWilmington, N.C. With offices in 48 other countries. With experience, commitment and quality it helps its customers clients and patients in the best cost and time.
2.3 Services
Following services is offered by the department they help to improve health by life changing therapies. It offers
Clinical trial management services include investigator recruitment, study design, clinical data management and bio statistical analysis.
The PPD Company also offers patient and disease registry programs and product launch services.
From discovery to production it includes strategy and planning of product development
At selected contractors chemical and product development management
Manage supply and packaging for clinical studies.
Pharmaceutical consulting on product including clinical trial formulation development
Low cost API CITATION pra l 1033 (Anon., n.d.).
3.0 Similarities between PPD and PRAFollowing are the major similarities among the two organizations
The clinical data integrity is of supreme importance for the success of a project. PPD and PRA ensure this data integrity by strictly adhering with the review procedures and established operating during each stage of the project
Both organizations work in close coordination with the client on a specific clinical research for determining the particular requirement and customizing the software application for meeting the data storage need and processing need of each client.
Offering a complete drug management process
Direct interaction with the patients of clinical trial
Testing and investigation of the drugs for evaluating the safety, range of safe dosages, and identification of side effects
Organization and gathering of the clinical trial data using latest technologies
Assure high level of quality through their highly competent and educated research staff
Both provide site management and monitoring services
4.0 Dissimilarities between PPD and PRA4.1 Pharmaceutical Product Development
PPD is offering their efficient service of research in particular area by using multiple sources for collecting the data which include the following CITATION PPD l 1033 (Anon., n.d.)PPD investigator, clinical trial, and laboratory data
De-identified data of the patient
Competitive past trial data
Patented site data
Electronic medical records and electronic health records
PPD is providing high services by ensuring that the reviewed data is of the highest quality as their clinical research associates (CRAs) are highly skilled and efficient in conducting on-site monitoring for checking the collected data, reviewing the case reports and source documentation, ensuring the regulatory compliance, resolving queries related to the data, etc. They also provide interim analyses if additionally requested by the client
PPD has advanced their clinical research by providing analytics platform Preclarus which enable real-time and easy access to lab data and study. It also provides analytic capabilities and transparent reporting needed for making critical decisions. Preclarus is an all-inclusive data solution which standardizes and consolidates data from different sources and after collecting it give it to the PPD teams.
PPD used different electronic data capturing software which are highly efficient including Oracle Clinical/Remote Data Capture, Oracle InForm, Medidata Rave.
PPD is offering quality upfront design and full assistance which is very useful in decision making process, reduce risk and errors, quality and global infrastructure with the help of services and clinical biostatics. Their major work related to biostatics include the following
PPD provides study design, analysis, Clinical development planning and endpoint strategies, as well as cooperating statistical analysis plans and methodologies.
Projects need like UVR and IWR can be met with investigational product management, by Randomization schedule creation and integration.
with efficient, quality production of full-output deliverables provides scientifically sound interpretation and reporting of results
frequent, automated secure Web postings and Real-time analysis presentations
operation of adaptive design studies for all phases of trials, from initial dose titration through post-approval services
Apart from this, PPD provide insurance of complete, concise reporting which is Based on a well-developed plan, the statistical analysis implementation provides clients with high-quality deliverables in time which resulted in increased productivity, saving time, and enhancing data security by a centralized computing platform
International Conference on Harmonization (ICH)-compliant Analysis strategies
tables, listings, audit-ready and figures Production
in Clinical Data Interchange Standards Consortium (CDISC) format New drug application (NDA) submission-ready and submissions of statistical sections
investigational new drug (IND) safety updates Data and safety monitoring board (DSMB) output, Development of comprehensive methods reports and interim analysis describing planned and detailed analyses
scientists to guarantee suitable interpretation of quantitative results by association with medical writers and clinical
maintain for manuscripts and abstracts
Global biostatistics of PPD team has a wide range of experience related to therapeutic, and our statisticians hold advanced degrees. with data-driven information, study design analysis, and interpretation we add value to client projects
4.2 PRA Health SciencesOn the other hand, PRA has expertise in the field of
Biostatistics and Medical Writing
They have medical writing, biostatistics, pharmacokinetics and regulatory publishing groups incorporated with experienced and trained therapeutically staff. They have skill and knowledge in statistical analysis, regulatory reporting and data pooling. This universal team give professional consulting proficiency and provide support to clients from the very initial phase of protocol plan during postmarketing inspection and PhaseIV studies. For publishing purpose, they employ a particular electronic system that ensure to flawlessly assemble, supervise and circulate composite documents in acquiescence with relevant dictatorial guidelines. CITATION PRA17 l 1033 (Anon., 2017)Quality Assurance Services
In the America, Europe and Asia Pacific their global quality assurance group is incorporated by a team of professionals. Their quality declaration department is totally separate from and autonomous of the employees occupied in the way and manner of clinical trials. The goal of the quality assurance group is the global endorsement of ongoing quality attentiveness and unremitting development of our processes. This group gives these efforts by performing audits on the processes and systems incorporated in the organization of clinical trials to guarantee fulfillment with study procedure and appropriate regulatory requirements and perform audits for a broad range of medical indications and in all phases of clinical trials crossways the world.
Embedded Solutions
They present a well scalable, entirely embedded clinical development clarification. Their embed Solutions model is considered to join clinical operations knowledge, organization, road and rail network and support to generate an elastic and integrated working model.
CustomBuilt Development Solutions
They are offering a conventionbuilt expansion solutions to present people, process, systems and development skill that allow the well-organized interior development of a companys creation portfolio with better control and elasticity, accelerated growth timelines and considerably reduced expenses. With the clients core management in control, they assist to construct the expansion team, whereas enabling the clients to uphold the flexibility to be quick during the development lifecycle.
5.0 Selection of the CROTherapy Area Neurology
Services Required Study related to the Alzheimers disease
The main aim of the project is assessing the cognition change and daily living change. Being a Manager, I have selected Pharmaceutical Product Development for Neurology Therapy Project. As PPD has special expertise in managing the nervous system disorders. They have a dedicated team of neurosciences and therefore they deliver the therapies in most quick and efficient manners. Physicians, pharmacists and additional medically skilled professionals are part of global pharmacovigilance team and their experienced team work together with clinical development, regulatory affairs and others, to make certain utmost success for neurology program. comprehensive, end-to-end services and medical device organizations. The Clinical team of PPDs and medical professionals are well trained in providing the services related to the peripheral nervous system, sleep medicine, disorders of central nervous system (CNS), and pain management. My selection of PPD is also based on their unique service in terms of providing a real-time interface with main laboratory, ancillary systems, and imaging for improving the data acquisition speed and review which lead to improved data quality and minimizing the risks related to the timeline CITATION the l 1033 (Anon., n.d.).
Following are the major services offered by the PPD for the selected therapy
Preclinical program design.
Toxicology consulting lab services.
Compound collaborative programs.
Technical writing and regulatory submission.
They have access to strong network of worldwide resources which include psychiatrists database of the investigator, sleep and pain specialists, neurological surgeons, neurologists, gerontologists, that provide a reliable access to qualified investigators
PPD team has undertaken similar project and adopt the following approach disease modification and symptomatic treatment. They start with initial identification and intervention of the patient. Their accelerated enrollment solution business unit provide best in class enrollment and site solution through industry leaders Acurian, Synexus, and Optimal Research. While planning and execution phase of studies, they use a real scenario by listening to the patients voice and operationalize the retention strategies. For ensuring the addition of appropriate patient in the trial, the departments neuroscience physicians team used a prospective protocol and review the targeted eligibility. CITATION Alz l 1033 (Alzheimers Disease, n.d.) References
BIBLIOGRAPHY Alzheimers Disease (n.d.) PPD.
Anon., 2017. PRA HEALTH SCIENCES, INC. Annual Report, s.l. s.n.
Anon., n.d. http//abracro.org.br. Online Available at http//abracro.org.br/pt-br/institucional/nossos-associados/236-pra-health-sciences
Anon., n.d. PPDI. Online Available at www.ppdi.com
Anon., n.d. prahs. Online Available at https//prahs.com
Anon., n.d. therapeutics/neuroscience. Online Available at https//www.ppdi.com/therapeutics/neuroscience
Craig J. Reist Tyrus L. Rorick Lisa G. Berdan Renato D. Lopes, 2013. The Role of Academic Research Organizations in Clinical Research. In Understanding Clinical Research. s.l.McGraw-Hill Education.
 

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