CRO Services (Phase I-III) Partners
Clinical Trials are required for drug therapies to receive regulatory approval.
A Phase 1 trial is the first to involve human subjects, and their objective is to determine the highest does of a treatment that can be safely administered to patients. A Phase 2 trial is conducted on a small number of patients to determine if the drug is effective. If the Phase 1 and Phase 2 trials are successful, a larger Phase 3 trial is conducted to gather data to present to the FDA. In a Phase 3 trial a drug is often tested against a placebo or the current standard of care. Clinical trials are expensive and time consuming, and they require expertise in many areas. Sponsors need to perform study startup (which includes site selection and patient recruitment), manage and oversee the trial, and collect and analyze trial data. All of these operations can be performed by a CRO.
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Looking for help with your Phase I-III project? If you're searching for information or a supplier, let Clinical Leader lend you a hand.
Altasciences
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.
Bioforum the Data Masters Inc.
Bioforum is a data-focused contract research organization (CRO), serving clients worldwide in optimizing the collection, standardization, and reporting of clinical research data. We strive to consistently improve and innovate data processes, enabling the most efficient data submissions for our clients across the life sciences industry worldwide. Our multidisciplinary team provides in-depth expertise and delivers high-quality solutions, including medical writing, data management, biostatistics and statistical programming.
Biorasi
Biorasi is an award-winning contract research organization accelerating drug and device clinical development for life sciences companies around the world. Since 2002, Biorasi has achieved success in bringing innovative therapies to market for our sponsors. Biorasi solves the problem of poor clinical trial performance with better patient recruitment, powerful data insights, and operational excellence. We deliver faster, higher quality clinical trials.
Capabilities
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CMIC Group
CMIC was founded in 1992 as the first CRO in Japan. To enable pharmaceutical companies to develop better medicine sooner, we expanded our solutions to include contract development and manufacturing, site support, and market solutions, supporting global companies to bring highly desired treatments to the Japanese market, to consult and conduct Asia clinical trials, or to bridge drug development and manufacturing needs between the US and Japan.
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Harbor Clinical
Harbor Clinical is a women-owned clinical research services firm with headquarters in the Boston biotech area. As a Functional Service Provider (FSP) offering Staff Augmentation, Consulting, and Single-Service resourcing models, Harbor Clinical's mission is based on the goal of forging innovative partnerships, with sponsors and employees, built on a bedrock of communication and transparency.
inSeption Group
inSeption distinguishes people as the most impactful variable in the outsourcing equation. Our path-breaking model attracts biopharma companies who demand a partner that shares in their drive to conduct impeccable development and will provide quality and dependable clinical solutions. We offer full outsourcing, consulting services, and functional service provider (FSP) solutions.
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IQVIA Biotech
IQVIA Biotech delivers flexible clinical development solutions designed to help biotech and emerging biopharma companies get treatments to patients. When you partner with our clinical team, you gain expertise from two decades of running clinical trials exclusively for biotech companies. We understand the unique challenges, hurdles, and opportunities you face. From strategy and trial design to execution, we draw on this experience to put together the right solution for you.
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IQVIA Integrated Global Compliance
IQVIA Integrated Global Compliance offers a complete lifecycle approach that brings together safety, regulatory, quality, and medical information to transform how life sciences companies sustain compliance and how compliance functions perform better together.
By integrating services, technology, and analytics, we can help bring together disparate compliance functions, resulting in heightened patient safety, improved compliance performance, and proactive insights power by IQVIA Connected Intelligence.
KPS Life
Founded in 2006, KPS Life is a standalone functional service provider (FSP) that offers global functional clinical trial outsourcing services to sponsors. Its services include clinical monitoring, clinical oversight, clinical trial management, data management, eTMF and document management, vendor qualification, and medical writing. KPS Life is uniquely devoted to providing customized, outsourced clinical solutions to pharmaceutical and biotech customers of all sizes across all stages of clinical trials.
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Novotech
Novotech is internationally recognized as the leading Asia Pacific-centered Biotech CRO with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services, and FDA regulatory expertise and has experience in over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US, and Europe.
OCT Clinical
OCT is the leading contract research organization in Russia. Since 2005, OCT's team has conducted over 300 clinical trials in 29 therapeutic areas in Eastern Europe and the CIS region. Our team of 150+ clinical professionals provides a full range of high-quality CRO services for Phase I-IV and BE studies, with therapeutic expertise in oncology, infectious disease, and all major therapeutic indications.
Precision ADVANCE
Precision ADVANCE is a collection of interconnected services and complementary teams uniquely focus on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring cell or gene therapies to market. Learn more about how we accelerate clinical development with Precision for Medicine, optimize next-gen manufacturing with Project Farma and drive commercial success with Precision Value & Health.
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Premier Research
Premier Research believes in a holistic approach to clinical development. From regulatory consulting, to product development, to innovative study designs and patient-centric solutions, we consider your study from every angle to maximize success. Our Built for Biotech℠ model is rooted in flexibility, and we are dedicated to helping the most innovative biotech, specialty pharma and medtech companies take their best ideas from concept to commercialization.
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Veristat
Veristat, a global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval. With more than 26 years' experience in clinical trial planning and execution, Veristat is equipped to support any development program. Our team has prepared over 100 marketing applications for approval with global regulatory authorities in the last 10 years alone.
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