#ClinicalResearchOrganization

[bioaccess]

Partner with bioaccess® – Your Trusted Medical Device CRO

It might be intimidating to navigate the intricacies of medical device clinical research. bioaccess®, a top medical device CRO, is here to streamline the procedure and quicken your time to market because of this. We offer customized solutions to match the unique requirements of MedTech enterprises, with a focus on the Latin American market.

At every stage of your journey from managing clinical trials to submitting to regulatory bodies, our team of professionals guarantees excellent outcomes. Our extensive network of clinical research sites and our established connections with regional regulatory bodies enable us to assist you in obtaining dependable trial results and expedited approvals.

Why Choose bioaccess® as Your Medical Device CRO?

Regulatory Expertise: Proven strategies for navigating Latin America’s complex regulatory landscape.

Comprehensive Trial Management: From feasibility studies to post-market surveillance, we handle it all.

Efficient Patient Recruitment: Effective recruitment strategies for diverse patient populations.

Accurate Data Collection: High-quality data management ensuring reliable and compliant results.

Tailored Solutions: Customized services to fit your medical device’s unique requirements.

You receive a partner with bioaccess® who is committed to ensuring the success of your clinical studies and a smooth market launch. We can help you whether you're increasing your market reach, performing pivotal trials, or pilot research. Contact us today to discuss your clinical research needs.

[clinicaltrialresearcher]

Regulatory Foundations in Clinical Research: Crafting Effective Clinical Trial Protocols A clinical trial protocol is the backbone of any study, outlining objectives, methodology, and compliance measures. It ensures consistency, ethical adherence, and participant safety while being approved by regulatory bodies. Key Elements of a Protocol: ✔ Study objectives, design, and endpoints ✔ Participant eligibility criteria ✔ Data collection and analysis plans Why Protocols Matter: 🔹 Ensure regulatory compliance 🔹 Maintain trial integrity and reproducibility 🔹 Guide research teams effectively Common Challenges & Solutions: ❌ Complex designs → ✅ Use participant-friendly approaches ❌ Protocol deviations → ✅ Regular reviews & refinements 💡 Pro Tip: Mastering protocol design improves trial quality and career growth! 🌐 Visit: ccrps.org 🔗 Build better protocols—enhance your research skills today!

[market-insider]

Clinical Trials : Holistic Exploration of the Current State and Future Outlook

The global clinical trials market size is expected to reach USD 123.5 billion by 2030, expanding at a CAGR of 6.49 from 2024 to 2030, according to a new report by Grand View Research, Inc. An increase in the volume and complexity of clinical trials has been witnessed lately, which plays an important role in the R&D of new drugs and products. The market witnessed a decline of 6% in 2020 owing to the COVID-19 pandemic. However, the market is projected to recover from 2021 onwards. In addition, clinical trials have become increasingly costly, adding to the overall cost of developing a drug.

Clinical Trials Market Report Highlights

The phase III clinical trials segment dominated the market with a 53.3% share in 2023. This can be attributed to the complexity of this phase

The interventional studies segment dominated the market in 2023. It is one of the most prominent methods used in clinical trials in the study design segment owing to the increasing demand for the intervention for clinical trials by researchers

North America held 50.3% of the market share in 2023. Favorable government initiatives and the presence of a large number of players in the U.S. that offer advanced services are responsible for market growth

Asia Pacific region is anticipated to grow at the fastest CAGR over the forecast period owing to the increasing patient pool and cost-efficient services.

For More Details or Sample Copy please visit link @: Clinical Trials Market Report

The increasing need for developing new drugs for chronic diseases, such as cancer, respiratory disorders, diabetes, cardiovascular diseases, and others, is creating immense pressure on the healthcare industry. The COVID-19 pandemic and the increasing demand for developing a suitable treatment are driving the market. The high number of people affected by the disease further depicts an increasing need for therapeutics & vaccines. Currently, there are 288 therapeutics and 106 vaccines under development, out of which, nearly 7.0% of therapeutics are in Phase IV, 21.0% in Phase III, and 43.0% & 13.0% in Phase II & Phase I, respectively.

The pandemic has resulted in the global disruption of traditional onsite clinical trials. Hence, regulatory bodies worldwide have undertaken various initiatives for fast-tracking clinical trials for the development of innovative solutions. One such instance is Solidarity, an international clinical trial launched by the WHO to find effective treatment against COVID-19. Although the pandemic has forced many medical device & drug developers to revise the approach to such crises, integrating best practices within clinical trial procedures & adapting to virtual trials, which can support the continuous development of therapeutics.

ClinicalTrials #HealthcareResearch #MedicalInnovation #DrugDevelopment #PatientRecruitment #Biopharmaceuticals #ClinicalResearch #RegulatoryCompliance #DataManagement #PatientEngagement #PrecisionMedicine #TherapeuticTrials #CROs #ClinicalResearchOrganizations #GlobalHealth #ClinicalStudyDesign #PharmaceuticalIndustry #BiotechResearch #ClinicalEndpoints #HealthTechIntegration

[prorelixcro]

Clinical Trial Operational Services

Clinical Trial Operational Services refer to the range of activities and support provided to facilitate the execution and management of clinical trials. These services cover various aspects of trial operations, ensuring smooth and efficient conduct of the study. Here are some key components of clinical trial operational services:

Site Selection and Management: Clinical trial operational services include identifying suitable investigative sites and assessing their capabilities to conduct the study. This involves evaluating site infrastructure, patient recruitment potential, and compliance with regulatory requirements. Once sites are selected, ongoing management and oversight are provided to ensure adherence to protocols, data collection, and timely reporting.

Patient Recruitment and Retention: Services related to patient recruitment and retention are crucial for the success of clinical trials. Operational teams work on developing strategies and implementing tactics to identify and enroll eligible participants. They also employ engagement and retention initiatives to enhance patient compliance, improve data quality, and minimize dropout rates.

Study Start-up and Regulatory Support: Clinical trial operational services encompass assistance with study start-up activities, including obtaining necessary regulatory approvals and ethics committee submissions. Teams provide guidance on developing study protocols, case report forms, and informed consent documents that comply with regulatory requirements. They also ensure adherence to local and international regulations and guidelines throughout the trial.

Clinical Data Management: Effective data management is critical for clinical trials. Operational services include designing and implementing data capture tools, such as electronic data capture (EDC) systems, to collect and manage study data securely. Data validation, quality control, and data cleaning processes are also part of these services to ensure data accuracy and integrity.

Monitoring and Quality Assurance: Monitoring activities are conducted to ensure that the trial is conducted in compliance with protocols, regulations, and good clinical practice (GCP) guidelines. Clinical trial operational services include site monitoring visits, source data verification, and assessment of protocol adherence. Quality assurance measures are implemented to maintain high standards and identify any issues or risks that may impact the integrity of the trial.

Project Management: Effective project management is crucial for the successful execution of clinical trials. Operational services encompass project planning, budgeting, timeline management, and coordination of various stakeholders involved in the trial. Project managers oversee the overall trial operations and ensure efficient communication and collaboration among team members.

Safety Reporting and Pharmacovigilance: Operational services include the management of safety reporting and pharmacovigilance activities. Teams are responsible for the timely and accurate collection, assessment, and reporting of adverse events and serious adverse events. They ensure compliance with safety reporting regulations and provide ongoing safety monitoring throughout the trial.

Regulatory Compliance and Audit Support: Clinical trial operational services assist sponsors in maintaining regulatory compliance throughout the trial. Operational teams are experienced in conducting internal and external audits, ensuring that trial activities adhere to regulatory requirements. They provide support during regulatory inspections and address any findings or queries raised by regulatory authorities.

Clinical trial operational services play a crucial role in ensuring the successful execution of clinical trials. These services are designed to optimize trial operations, enhance data quality, and ensure compliance with regulatory standards. By outsourcing these services to experienced and qualified providers, sponsors can streamline their trial operations and focus on the core aspects of their research.

[prorelixr]

ProRelix Research is the best clinical research organization (CRO) with global service capability supporting Phase 1, 2, 3 and 4 clinical trials for Pharma, Biotech, Biopharma, Medical device, Nutraceutical and Herbal companies. Our excellent team of researchers have been working on clinical development plans of our clients with outstanding clinical research services in US, India, Australia and Europe. To know more please visit our website at www.prorelixresearch.com

[crfwebus-blog]

CRFWeb helps in BA/BE Bio availability and Bio equivalence  | CRFweb

CRFWeb helps in BA/BE Bio availability and Bio equivalence by providing ePRO and eDiaries in a more efficient way when compared to others.

BA BE studies Bio availability and Bio equivalence studies typically require rapid turnaround. Short studies have typically been the domain of paper trials due to the lengthy set up time and costs of traditional systems being impractical.

Increasing Regulation Those involved in BA/BE studies are currently finding themselves under pressure to adhere to new regulations and guidelines. This inevitably increases the volume and complexity of the paperwork required. Read more about the impact of regulations on BA-BE studies by following the link.

How CRFweb can help CRFweb, can help with all of this. In terms of turnaround, a simple BA-BE study eCRF can be set up in as little as a day on our EDC platform. If needed we can offer patient-reported outcomes, ePRO, and eDiary. Relevant reports, sample documents etc can be uploaded onto our eTMF (electronic trial master file) module. Critically for regulation and audit purposes, all activities have an audit trail.

A comprehensive range of standard reports are available and bespoke ones can be created if needed to facilitate swift and efficient hand over to your statistician.

Your BA BE study will be created on a system that is FDA compliant and to GCP (Good Clinical Practice) standards.

[celtishealthcare-blog]

Phases of Clinical Trials

Phase I

Tolerability or PK as primary endpoint in the protocol, independent of the study population and secondary parameters.

Study types included

Safety & Tolerability studies (Single/ multiple dose in patients or healthy volunteers)

Oncology studies in patients with tolerability / MTD as primary endpoint (efficacy might be a secondary endpoint)

Drug-Drug interaction & Food Effect

PK in renal or hepatic impaired patients

Phase IIA Exploratory (non-pivotal) study that has clinical efficacy, Pharmacodynamicsor biological activity as primary endpoint, conducted in patients or healthy volunteers.

Proof of concept, efficacy, or mechanism

Mechanistic studies

Dose range exploration

Pilot studies

Phase IIB Definite dose range finding study in patients with efficacy as primary endpoint.Exceptionally, Phase II studies can be used as pivotal trials, if the drug is intended to treat life-threatening or severely-debilitating illnesses as in oncology indications

Definite dose finding studies

Extension studies of Phase IIB studies

Phase IIIA A Pivotal* study that is a trial designed & executed to get statistically significant evidence of efficacy and safety as required by HAsfor NDA / sNDA approval.It also includes studies with the aim to include claims into the label as well as Post marketing commitments.

Pivotal studies (vsplacebo / comparator)

Long term saftey studies for registration

Local registration studies

Post marketing study commitments

Phase IIIA extension studies

Phase IIIB A study started prior to approval and whose primary intention is support of publications rather than registration or label changes. The results are not intended to be included in the submission dossier.

Studies intended to support publication, claims or to prepare launch, which start before approval but are not intended for Regulatory submissions

Phase IV A study started after approval with primary intention to support publications rather than registration or label changes The results are not intended to be included in a submission dossier.

Post Marketing Surveillance studies

Studies intended to support publication claims

Clinical Development Plan (CDP)

It bridges the gap between vision and the day -to -day activities of large multidisciplinary organizations.

The vision is transformed into distinct implementation phases and discrete steps, called clinical studies, each with well defined milestones and deliverables. To know more, visit  www.celtishealthcare.com

[bioaccess]

Your Trusted Medical Device CRO Partner: bioaccess®

bioaccess® is a leading medical device CRO, specializing in accelerating your product's journey to market. We offer comprehensive clinical trial management, regulatory affairs, and market access solutions. Partner with bioaccess® for expert guidance and streamlined execution, ensuring successful and compliant medical device development.

[crfwebus-blog]

Technology partner for Contract Research Organisations CROs | CRFweb

As a technology partner for Contract research organisations CROs CRFWeb offers eCRF, ePRO, eDiary, eTMF, MedDRA coding, double data entry, randomisation.

CRFweb is a state-of-the-art EDC application, developed from the ground up to deliver a system that offers the key features you will see among the big name market leaders, but at a fraction of the cost. Most importantly we are set up to work as a technology partner for CROs.

[celtishealthcare-blog]

Contract Research Organization - Celtis Healthcare

[celtishealthcare-blog]

clinical trial phases in India - Celtis healthcare