Clinical Research Organizations (CROs) require a flexible operating model to carry out streamlined trials, enhance coordination between all stakeholders, arrive at fast decisions quickly, ensure top productivity with consistency and be transparent in their operations to sponsors. Ensuring all of these together has always been a challenge for a CRO service provider. However, with outsourced clinical research, much of the complexities involved in ensuring these at all times can be sorted with ease.
As a clinical research organization services providing company, Outsource2india has over 24 years of experience in providing clinical research organization services to biopharma companies worldwide. Over the years we have supported the needs of these companies with an end-to-end range of services driven by strategic planning and quality control. As a premier CRO services company, we have conducted more than 1000 clinical projects for diverse requirements and supported the development of several metabolic drugs and devices at a global level.
Our Clinical Research Organization Services
We offer a diverse range of CRO-related services with equal competency. Some of these services include -
Our regulatory affairs services for CROs involve creating bespoke regulatory programs for operations in alignment with required regulations specific to drugs and device discovery for metabolic diseases and other clinical research needs. We assist our clients in analyzing global regulatory requirements and available paths; 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
Our vendor management processes help you draw a strategy to identify vendors based on your requirements. This includes factors such as qualification and governance processes for vendors. We 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, and so on. Other things we look into include location site, metabolic expertise, and access to the right kind of patient populations.
Our medical writing services for clinical research organizations are designed to assist CRO companies get all their documentation needs met. We have a team of PhD-level medical writers with wide experience in metabolic clinical writing. We leverage their expertise to provides customized medical writing such as target product profiles, study protocols, clinical study reports, medical journal submissions, scientific abstracts, and presentations. We bank on document management and electronic publishing tools to meet International Conference on Harmonization (ICH) and Food and Drug Administration (FDA) guidelines.
Our project management service looks after your end-to-end clinical research management needs. We have a robust team of leaders, with years of experience in managing highly complex metabolic studies and multinational operations. Their experience has been enriched by their clinical research knowledge and day-to-day interactions to manage projects. We assign our clinical project managers to a maximum of two clinical trials. Their scope of work entails an end-to-end execution of a specific clinical protocol and finally culminates with the transfer of deliverables.
Patient Access and Subject Enrollment
With this service, we assist clinical trial sponsors to get access to patients, accelerate patient recruitment, and initiate clinical trial awareness. We have a well-developed patient access process to speed up the medical study process and ensure trials are conducted at reduced costs and time. Our primary tasks include identifying patient profiles, driving patient enrollment, and providing extended support if needed to carry out a study at the patient's home. The extended support includes drug delivery, drug administration, and nursing care at the patient's home. We bank on an on-site recruitment team and a patient database of over 1 million study participants.
Our clinical monitoring services are designed to identify mistakes and risks in a trial. We deliver this service with the help of a dedicated team of clinical monitoring specialists located around the world. All our clinical monitoring experts have extensive experience in clinical research procedures and compliance requirements and so can proactively identify every type of error in the process. Our clients bank on monitoring services to deliver services in keeping with the trial procedures, accepted operating procedures (SOPs), GCP/ ICH guidelines, and other specific regulatory requirements.
Medical Monitoring and Pharmacovigilance
With this service, we assess, monitor, and report on the comprehensive risk-benefit profile of products under clinical development. We have wide exposure in effectively 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. Our end-to-end services include customized safety monitoring, continuous support for safety review, safety database services, risk-benefit analysis, medical monitoring, and so on. Backed by over 500 clinical trials for metabolic diseases we ensure that our clients' monitoring requirements are in safe hands.
Clinical Data Management
Our data management service assists clients to get round-the-clock access to real-time trial metrics. The objective is to provide anytime updates on the progress of a clinical research program. Our exclusive service in this domain includes 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. Our clients bank on our high-quality and reliable trials to prove and disprove hypotheses and reduce the time needed from drug development to marketing.
We bank on a multidisciplinary biometrics team to deliver customized biostatistics to support each client's unique clinical development project. Our end-to-end services cover research design and process development as well as research analysis for an agency meeting and regulatory submission. The scope of our services 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 experience in applying scientific principles has assisted our clients to make the clinical development process streamlined and result-oriented.
Other Clinical Research Organization Services
Besides the above-mentioned core CRO services, we also offer the following services -
Automate Business Processes - We assist you to automate and optimize all your clinical trial activities with our automation process. In the process, we help you keep the costs down and meet regulatory timelines.
Business Transformation - Our business transformation process speeds up your trial method by assessing, implementing, and streamlining processes to orchestrate research methodology.
Automated Testing - We automate end-to-end workflow testing of various CRO applications. We bank on open-source, commercial, and in-house automation solutions for testing applications.
Our Clinical Research Organization Process
Designing excellent clinical research takes experience and considerable expertise. We follow standard recommendations for reporting randomized controlled trials. At the same time, we base our research process on a checklist of items that must be part of observational studies. Our well-defined process which is tailored to produce the best results consists of the following steps -
01. Understanding Research Requirements
We sit with you to understand the clinical trial requirements. There are several pre-requisites that need to be met before a clinical trial can start. A proper understanding helps us define roles during the trial as well as specify reporting obligations at the end of the trial. Once this is achieved, the trial protocol is created to define objectives, design, methodology, statistical considerations, etc.
02. Research Preparation and Approval for Protocol
Once the understanding is acquired, we determine if your research requires institutional review board approval. This is to ensure you can publish your research. In case of a requirement, we determine which UW IRB is the correct IRB for review and zero in on the exact applications to use. We assign you with faculty reviewers to reviews all materials before sending them for departmental review. This helps in ensuring the right material is submitted to the UW IRB
03. Patient Screening
As only some patients can be part of the clinical trial, 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. With our patient screening service, we help to protect the health of patients so that the ones chosen can benefit safely
04. Informed Consent
As patient participation in a research study is purely voluntary, we help you procure 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
05. Phase Trial - 0, 1, 2, 3, & 4
We provide all back-office support for all stages of clinical research. In the phase 0 stage, we assist in doing it with a small number of people. In other stages, we assist our clients to carry out the trials with a different number of people as mandated by the FDA. The objective of all the phases is to establish that the treatment is safe. During all the stages 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
Other Services You Can Benefit From
Benefits of Outsourcing Clinical Research Organization Services to Outsource2india
As an established CRO services company, we offer a host of benefits to our clients. Some of these include -
Assured Reduction in Expenditures
We have a track record of assisting CRO companies to reduce or eliminate the need to invest in in-house infrastructure, hire research staff, and cut down on risks that can lead to loss by effectively managing uncertain outcomes. Our clients have leveraged our services to boost success rates and speed up drug discovery and development thereby leading to higher profits with little investments. In an age where pharmaceutical companies have seen a fall in profits, outsourcing can help them sustain themselves.
Expert Team of Research Analysts
We are driven by a team consisting of a principal investigator, associate investigators, study coordinator, biostatistician, programmer, data manager, etc. The team is built depending on the complexity of the project, deadline, and budget. The principal investigator plays a major role in planning, tracking, prioritizing, and communicating the project. The principal investigator ensures that a case-wise timeline and deliverables are provided to the client.
Adoption of the Right Methodology
We have developed the right methodology to handle every aspect of clinical trials. The methodologies are customized as per client and research needs. This helps in ensuring that we can match up to the need of the ever-changing clinical landscape. Our multidisciplinary teams are trained in all phases of clinical development methodology and can work in tandem with local talent. It is because we bank on the right methodology and practice that we can deliver the most accurate results on time.
Up-to-date Communication with Frequent Meetings
We have a well-developed communication process, which is backed by routine and frequent meetings with clients. While we insist on a weekly meet, we also make ourselves available for daily meets. The meets are used as an opportunity to share information on team strategies, results and lessons learned across the spectrum of weekly/daily activities.
Complete Transparency in Outcomes
A hallmark of our clinical research service is transparency. We leverage transparency of processes to make the outcomes more effective. We are transparent in the handling of data and share every detail with clients and patients. Our commitment to transparency has helped us win the confidence of patients' advocates, investigators, and doctors. The result of this confidence has always been doing away with stigmas and wholehearted participation in the trial.
We specialize in coming up with proof-of-concept studies to demonstrate efficacy at the early phase. We have a robust record of reproducibility for generating clinical proof-of-concept in a quick time. Our proof of concept has helped our clients attract many development partners.
Handle Increasingly Complex Drugs and Clinical Trials
Drug development has become more complex with time. Advancements in gene therapies, the use of cytotoxic compounds, antibody-drug conjugates, in vitro and in vivo methods, and other modern-day evolutions have added to these complexities. By outsourcing CRO, companies can bank on partners who are continuously embracing new technologies and improved processes to handle complex trials with the highest performance for guaranteed efficiency and accuracy.
Reduced Time to Market
Third-party partners specializing in research trials have the infrastructure and skills to handle complex services with great efficiency. Their ability to modify drug candidates in real-time can speed up the research process and thus shorten lead times enabling pharmaceutical businesses to take products to market sooner and get an edge over the competition.
To help accelerate research trials we work round the clock from different global centers around the world. No matter what our client's time zone is, we ensure a part of our team is always available to interact and update the client on the progress made. Our clients rely on our 24/7 availability to speed up the trial and be quick to market.
Client Success Stories
O2I Helped with Patient Onboarding for a Leading Healthcare Company
A leading women's reproductive services provider was looking for patient onboarding services. We provided the client with the best quality services.Read more
O2I Assisted a US-based Medical Billing Organization with ICD-10 Transition
O2I trained an in-house team from a Florida-based medical billing company to transition to ICD-10 coding from ICD-9.Read more
I could not be happier with my decision to work with you. I look forward to our continued relationship and growth.Owner, Medical Billing Services Company, California, USA More Testimonials »
Outsource Clinical Research Organization Services to Outsource2india
Outsource2india has 24 years of experience as a back-office CRO service provider. Over the years we have gathered the expertise to understand the challenges that all CRO companies face in their journey and have devised strategic ways to negotiate the challenges so that productivity remains high at all times. Our deep domain expertise in drug development and disease management and automation-driven, analytics-modeled, and cloud-based work processes will help you come up with innovative solutions in the shortest possible time and most cost-effective rates. We have a successful track record of enabling businesses to reduce time and effort by up to 60%. At the same time, our solutions and services have enabled the highest level of business optimization and facilitated real-time strategic insights for informed decision-making.
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- US-based Healthcare Research & Consulting Firm Approached O2I For Medical Transcription Services
- Outsource2india Provided Patient Onboarding Services to a Leading Healthcare Company
- Outsource2india Assisted a Florida-based Medical Billing Company with ICD-10 Implementation
- Caribbean Radiologists Got STAT Reports Automation Services from Outsource2india
- Outsource2india Helped a Medical Imaging Firm with Quick Teleradiology Services
- O2I Processed Over 3000 Encounters Related to Rehabilitation Care for a Group of Physicians from Indianapolis