Medical Research Organization Services enables to operate streamlined trials flexibly which helps the stakeholders in taking decisions quickly, ensure productivity with consistency and transparency in their operations to sponsors. Therefore, with outsourced medical research organization services all the complexities are sorted with ease.
We at GSB LPO Services has years of experience in providing medical research organization services to bio-pharma companies worldwide. Our services are an end-to-end range of services driven by strategic planning and quality control. We have successfully delivered projects for the diverse requirements of our clients at a global level.
MEDICAL RESEARCH ORGANISATION SERVICES WE AT GSB LPO SERVICES PROVIDE
- Regulatory Affairs – In this type of service we create certain regulatory programs for regulations of specific drugs and device discovery for metabolic diseases and other medical research needs. We assist our clients in analyzing global regulatory requirements and available paths such as NDA/ANDA and IND/CTA readiness assessment; collection and submissions of IDEs and INDs; arranging briefing documents and meeting requests and representing or briefing clients before regulatory authorities.
- Vendor and Site Selection – In this type of services we prepare a strategy to identify the vendors based on our client’s requirements. This includes factors like qualification and governance processes for vendors. Our experts evaluate vendors based on proven metabolic expertise, ethics and quality assurance audit, capacity and processes to meet clinical deadlines, evaluation of current or competing trials, data security systems, research professionals, location site, metabolic expertise, and access to the right kind of patient populations.
- Medical Writing – In this type of services we ensure that every medical writing service for medical research organizations is designed as per the requirement of our clients. Our experts are well trained medical writers with wide experience in metabolic medical writing. We also provide customized medical writing such as target product profiles, study protocols, clinical study reports, medical journal submissions, scientific abstracts, and presentations. The document is prepared with upmost care and perfection tools to meet International Conference on Harmonization (ICH) and Food and Drug Administration (FDA) guidelines.
- Project Management – In this type of service we ensure our client by providing end- end medical research management needs. Our experts have years of experience and enrich by their medical research knowledge on a day-to-day interactions to manage projects. Our experts are assigned with the medical project maximum of two clinical trials and limit the work entails to an end-to-end execution of a specific medical protocol.
- Patient Access and Subject Enrollment – In this type of service, our experts assist the medical trial sponsors to get access to patients, accelerate patient recruitment, and initiate medical trial awareness. We have successfully conducted trials which are cost cutting and time saving. Our primary tasks include identifying patient profiles, driving patient enrollment.
- Medical Monitoring – In this type of service our experts keep on check on the mistake and risks in a trail. This service is provided with the help of our medical monitoring professionals to clinical monitoring specialists located worldwide. We assure our clients on monitoring services as we deliver services of the trial procedures, accepted operating procedures (SOPs), GCP/ ICH guidelines, and other specific regulatory requirements.
- Pharma company vigilance – In this type of services our experts assess, monitor, and report on the comprehensive risk-benefit profile of products under clinical development. Our services are widely effective in evaluating the safety profile across all the stages of a development path and working hand-in-hand with clients, sponsors, and regulators to meet quality and compliance standards.
- Customized Services – In this type of service we provide an end-to-end services customized service such as safety monitoring, continuous support for safety review, safety database services, risk-benefit analysis, medical monitoring which is backed by over 500 clinical trials for metabolic diseases we ensure that our clients’ monitoring requirements are in safe hands.
- Medical Data Management – In this type of service, we assists our clients with the data management service to get round-the-clock access to real-time trial metrics. We provide an exclusive service in providing eCRF and database development via a robust clinical development EDC platform, delivering custom reports with the help of visual analytics, assisting in mobile and Web ePRO integration for on-the-go updates. We ensure our clients by delivering high-quality and reliable trials to prove and disprove hypotheses and reduce the time needed from drug development to marketing.
- Biostatistics – In this type of service, our experts deliver a customized biostatistics to support each client’s unique clinical development project which includes assimilation, analysis, and validation of data to ensure a smooth regulatory-compliant process, bespoke statistical analysis, listings, reporting, and figures, pharmacodynamic (PD) and pharmacokinetic (PK) parameter analyses, data report summarization for regulatory review, etc. Our experts are experienced in applying scientific principles and have assisted our clients to make the medical development process streamlined and result-oriented.
OUR EXPERTS UNDERTAKE THE MEDICAL RESEARCH ORGANIZATION PROCESS AS UNDER
Step 1 Accumulating Research Requirements – A detailed understanding of the pre-requisites needs for a medical research as this will help in achieving the trial protocol objectives, design, methodology, statistical considerations, etc.
Step 2 Research Preparation and Approval for Protocol – We determine whether the research requires institutional review board approval to ensure that our client’s research is published. The determining process is done by UW IRB for review and zero in on the exact applications to use as it helps in ensuring the right material is submitted to the UW IRB.
Step 3 Screening of patients – We screen patients to ensure they meet all the required eligibility criteria or inclusion criteria. Based on the proposed research, we ensure the selected patients meet the age criteria, necessary health conditions, type or stage of disease, and other factors. This process helps to protect the health of patients so that the ones chosen can benefit safely
Step 4 Consent of the Patient – We help our client in procuring the consent after considering all factors. We assist patients to understand the aspects of a research study so that they can choose to participate in the research. We explain the tests and procedures, the type of treatments included, how information is kept confidential, and so on. In case the patient is not an adult, we seek permission from the parent or a legal guardian.
Step 5 Phase Trial – Firstly, we assist in doing it with a small number of people. Secondly, we assist our clients to carry out the trials with a different number of people as mandated by the FDA. This is done to ensure safety after the trial phase is done we furnish the dose of the treatment given and the side effects of the treatment on different age groups and the different categories of patients.
WHY OUTSOURCE LEGAL PROOFREADING SERVICES TO GSB LPO SERVICES
Our experts are professionals having great experience to meet our clients precise Medical Research Organization needs; our clients receive benefits that may not be available by any other Medical Research Organization Service providers. We at GSB LPO Services have a large team of experienced and qualified Medical Research Experts who are specially trained to monitor various types of legal documents. We are well- known for the following benefits:
- Cost Effective – Medical Research Organization services is provided by professionals/vendors who are located in Asian countries and can offer services at competitive rates. We make sure that there is no compromise on quality; we ensure our services are delivered within agreed timelines.
- Complete Data Security – We ensure 100% assured data security; we take great care of our client’s legal contract/medical documents. The documents are always safe and are in trusted hands of GSB LPO SERVICES, we strictly comply with the rules and regulations to maximize data security.
- Certified Company –We are a certified company and hence abide by HIPAA compliance to ensure complete data safeguards. We ensure this with the right authentication policies and contingency plans. We also have the most advanced anti-virus, firewall, and infrastructure security. Hence, with this our Medical Research Organization Services are authentic and provide the best service.
- Regular Training – Our professionals are well-equipped with the latest technologies and compliance requirements which are acquaint to new joiners with our summary recording process, information access policy, data backup policies, etc.
- Quick Analysis – We ensure quick analysis of the client’s documents as structured documentation with proper indexing is done.
- Time saving – We arrange information in an arranged manner which takes no time to fetch the information.
- No paperwork – Our client’s documents are organized and digitized in a standardized manner. We choose correct templates according to the requirements of our client to make it look like a proper reproduction of the concepts and terminology coming with every guideline needed in the writing skills.
- Quality – We cross check the document thoroughly and it goes multiple quality check steps to eliminate any kind of errors. These are done by the professionals with a high level quality check mechanism. We also ensure readability, completeness, accessibility, and accuracy of our client’s information.
- Experienced Staff – Our team consist professionals with vast experience in medical research organisation services. Our team is capable of delivering the most challenging assignments with complete confidence for a successful outcome for our clients. Our medical experts are guided by a well-developed summary writing process that consists of systematic approach to gathering and documenting information, an organized method of identifying problems and diagnosis and a multi-tier quality check team.
- Customized Services-We provide customizable medical research organisation service which is best-in-class as well as editing services tailored to our client’s business size.
- Virtual Legal Proofreading- We offer internal and external medical research experts that give you virtual medical research organisation facility.
WHY HIRE Medical Research Organisation EXPERTS AT GSB LPO SERVICES
Our Medical Research Organisation Experts provide services which help in saving time and money. Our Medical Research Organisation Experts are available when our clients need them.
- We have a team of experienced and skilled professionals always there to help you 24*7 for preparing your required medical documents and several services and want to help as many people as possible. We use technology to make it easy for you to work with us.
- We have assembled a team of experienced legal professionals, management, commercial, contractual skills as medical research organisation experts for firms and other industries.
- Our medical research organisation experts execute the job with a positive attitude and a desire to help you improve your practice.
- We ensure that the client qualifies the documents under the law by researching.
- Our medical research organisation experts have a healthy legal mind, the ability to work with confidential budgets, excellent organizational skills and the ability to meet deadlines.
- We help keeping cases on track, track deadlines for every foams and ensures that the client’s documents are submitted before time.
- Every assignment that we undertake is managed by a senior member acting as the team leader, who takes responsibility for its successful conclusion.
We are the most trustworthy, GSB LPO Services focuses on advising and representing our clients by providing templates for our client’s case to prepare strong qualitative document as per our client’s needs. Our client’s package for settlement will be effective with our expertise. Most clients are looking for answers, not false promises. We entirely focus on results.
Here, we at GSB LPO Services look out for our clients by providing the best prepared document within less time which is prepared in the best way for our client’s claims.
From business support, documentations, strategy & business advice and also employee issues, they always bring smart and efficient solutions and have great contacts for legal support when it’s not their specialty. Our way of working is not complex at all. We believe that clients should get what they expect from us. One of the things that clients expect is a hassle-free session. Thus, we work in the simplest way possible. We have a team of experienced and skilled lawyers always there to help you 24*7.
Please send your file at our Dropbox: [email protected]and shoot an email at[email protected]and your assignment will be done.