Electronic Data Capture & Remote Data CaptureCRB Tech
CRB Tech is one of the best leading Software Development Company in Pune. We are offering Software Development Services as well as IT Training including Java, Dot Net, SEO and Clinical Research training in pune.
Electronic Data Capture & Remote Data CaptureCRB Tech
CRB Tech is one of the best leading Software Development Company in Pune. We are offering Software Development Services as well as IT Training including Java, Dot Net, SEO and Clinical Research training in pune.
Evidence Synthesis for Sparse Evidence Base, Heterogeneous Studies, and Disco...InsideScientific
Standard models in evidence synthesis work well in settings characterized by a large evidence base, the absence of effect modifiers, and connected networks. Handling sparse data, substantial between-study heterogeneity and disconnected studies, however, poses challenges to researchers and requires advanced methodology.
In the absence of head-to-head studies, evidence synthesis is a well-established technique to indirectly compare novel and established interventions in various disease areas. In standard settings, the most established methods for various outcome types work well and result in realistic effect estimates. However, there are a variety of situations when standard methods may no longer be sufficient:
- if there is only a sparse network of evidence
- if there is a large amount of between-study heterogeneity
- if the network is disconnected
Key Topics Include:
- General introduction into the objectives of conducting evidence synthesis
- Description of typical situations of “non-standard” data, including sparse networks of evidence, a large amount of between-study heterogeneity, or disconnected networks
- Advanced methods to address non-standard data, including the use of informative priors, subgroup analyses, meta-regression and multi-level meta regression, and matching-adjusted indirect comparisons (MAICs)
- Case studies illustrating how these advanced methods of evidence synthesis are applied on actual data
Explaining the Different Types of Routine Monitoring VisitsTrialJoin
In the clinical research industry, there are several types of basic monitoring visits that everyone involved in it should differentiate, especially CRAs (monitors). A CRA (clinical research associate) or a monitor is the person responsible for visiting a site in order to ensure that the clinical trial is being conducted properly. The CRA’s tasks include on-site visits and ensuring compliance, subjects’ safety, data quality and integrity, etc. Although clinical trials belong in the medical field, a CRA doesn’t have to be a doctor or a medical professional. It’s enough if a CRA has a background in Life Sciences, past experience in clinical trials (most often as a coordinator), and the proper training.
Presentation working on clinical trialsSarah Henter
Working on Clinical Trials – Getting started
Very few clinical trials are conducted only in one country; many are available in a variety of different sites in different places, so the translation and linguistic adaptation for different target cultures and languages becomes more important – but it’s not easy to find professionals who specialize in this specific field. With my presentation I hope to provide an overview of what makes the linguistic work on clinical trials so special, what kind of texts and target audiences there are and what knowledge linguists need to acquire in order to efficiently work in this area. This is especially interesting for translators who already specialize in the medical field, but also for linguists interested in legal, business, marketing and related field who would like to add an interesting niche with high demand to their specialization.
The presentation aims to be an introduction to the characteristics and requirements of the linguistic work on texts related to clinical trials. It not only wants to give a brief overview of how clinical trials work and who the stakeholders are, but also underline the skills and knowledge set linguists who would like to further specialize in this field should acquire. It also provides them with the necessary resources to get them started. The main topics are as follows:
• Introduction to clinical trials (what are they; how do they work; who is implied)
• Types of documents used in clinical trials (medical [specialist facing/ patient facing]; legal; marketing, etc.)
• Types of audiences (doctors/investigators/healthcare providers; patients/ other laymen such as healthy subjects/ partners/ legal representatives/ parents, etc.; ECs; CROs…)
• What skills do linguists need to work in this field?
• How to acquire that knowledge?
- Where to find glossaries/ templates/ further information
- MOOCs to take to get you started
- Books you should have read
- Other handy resources
A sponsor in literal terms is defined as an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical study.
In case an investigator independently initiates and takes full responsibility for a trial, he/she automatically assumes the role of a sponsor.
Investigator: A person responsible for the conduct of the study at the trial site.
Investigator is a person responsible for the rights, health and welfare of the study subjects.
Benefit-risk assessment is an integral part of FDA's regulatory review of marketing applications for new drugs and biologics. These assessments capture the Agency's evidence, uncertainties, and reasoning used to arrive at its final determination for specific regulatory decisions.
Evidence Synthesis for Sparse Evidence Base, Heterogeneous Studies, and Disco...InsideScientific
Standard models in evidence synthesis work well in settings characterized by a large evidence base, the absence of effect modifiers, and connected networks. Handling sparse data, substantial between-study heterogeneity and disconnected studies, however, poses challenges to researchers and requires advanced methodology.
In the absence of head-to-head studies, evidence synthesis is a well-established technique to indirectly compare novel and established interventions in various disease areas. In standard settings, the most established methods for various outcome types work well and result in realistic effect estimates. However, there are a variety of situations when standard methods may no longer be sufficient:
- if there is only a sparse network of evidence
- if there is a large amount of between-study heterogeneity
- if the network is disconnected
Key Topics Include:
- General introduction into the objectives of conducting evidence synthesis
- Description of typical situations of “non-standard” data, including sparse networks of evidence, a large amount of between-study heterogeneity, or disconnected networks
- Advanced methods to address non-standard data, including the use of informative priors, subgroup analyses, meta-regression and multi-level meta regression, and matching-adjusted indirect comparisons (MAICs)
- Case studies illustrating how these advanced methods of evidence synthesis are applied on actual data
Explaining the Different Types of Routine Monitoring VisitsTrialJoin
In the clinical research industry, there are several types of basic monitoring visits that everyone involved in it should differentiate, especially CRAs (monitors). A CRA (clinical research associate) or a monitor is the person responsible for visiting a site in order to ensure that the clinical trial is being conducted properly. The CRA’s tasks include on-site visits and ensuring compliance, subjects’ safety, data quality and integrity, etc. Although clinical trials belong in the medical field, a CRA doesn’t have to be a doctor or a medical professional. It’s enough if a CRA has a background in Life Sciences, past experience in clinical trials (most often as a coordinator), and the proper training.
Presentation working on clinical trialsSarah Henter
Working on Clinical Trials – Getting started
Very few clinical trials are conducted only in one country; many are available in a variety of different sites in different places, so the translation and linguistic adaptation for different target cultures and languages becomes more important – but it’s not easy to find professionals who specialize in this specific field. With my presentation I hope to provide an overview of what makes the linguistic work on clinical trials so special, what kind of texts and target audiences there are and what knowledge linguists need to acquire in order to efficiently work in this area. This is especially interesting for translators who already specialize in the medical field, but also for linguists interested in legal, business, marketing and related field who would like to add an interesting niche with high demand to their specialization.
The presentation aims to be an introduction to the characteristics and requirements of the linguistic work on texts related to clinical trials. It not only wants to give a brief overview of how clinical trials work and who the stakeholders are, but also underline the skills and knowledge set linguists who would like to further specialize in this field should acquire. It also provides them with the necessary resources to get them started. The main topics are as follows:
• Introduction to clinical trials (what are they; how do they work; who is implied)
• Types of documents used in clinical trials (medical [specialist facing/ patient facing]; legal; marketing, etc.)
• Types of audiences (doctors/investigators/healthcare providers; patients/ other laymen such as healthy subjects/ partners/ legal representatives/ parents, etc.; ECs; CROs…)
• What skills do linguists need to work in this field?
• How to acquire that knowledge?
- Where to find glossaries/ templates/ further information
- MOOCs to take to get you started
- Books you should have read
- Other handy resources
A sponsor in literal terms is defined as an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical study.
In case an investigator independently initiates and takes full responsibility for a trial, he/she automatically assumes the role of a sponsor.
Investigator: A person responsible for the conduct of the study at the trial site.
Investigator is a person responsible for the rights, health and welfare of the study subjects.
Benefit-risk assessment is an integral part of FDA's regulatory review of marketing applications for new drugs and biologics. These assessments capture the Agency's evidence, uncertainties, and reasoning used to arrive at its final determination for specific regulatory decisions.