Excellence in Clinical Trials and Research
By combining world-class expertise and technical innovation, with the highest standards of regulatory and quality assurance, we stand shoulder to shoulder with our clients as a seamless and reliable extension of their team – advising, guiding and supporting them from early research and discovery through to clinical development and commercialization.
Our dedicated team has vast experience in coordinating phase II to IV trials on both national and international scales. We can perform all stages of clinical trials – from feasibility to final study report – to the highest quality standards.
We have wide therapeutic experience, excellent cooperation with site staff, and in-depth knowledge of local requirements. Our core expertise and focus is in the South and South East Asia, however, we are able to cover the whole of Asia and many other countries through our partner CROs. Our resourcing model provides both the flexibility and local knowledge of each country that the study requires.
Monitors play a significant role in ensuring project success. As part of our commitment to Clinical Research Excellence, we designed the role of our monitors to go beyond simply meeting the technical accuracy demanded by the research.
Our CRAs (Clinical Research Associates) are trained to predict site management issues and proactively develop and implement solutions. They undergo a thorough instructional regimen and are highly trained. This approach is employed from the earliest stages and throughout the conduct of the clinical study, ensuring proper flow and responsiveness of the process.
All our monitors are full-time bilingual employees, equipped with laptops and are always available through mobile phones and the internet when they are off-site.
Whether helping your organization handle an overload of work on a single project or designing a full-service clinical program for your product, our clinical trials management team has experienced and knowledgeable staff members ready to assist you.
The way you establish, collect, manage, interpret, and prepare clinical trial data for submission can be the difference between a successful trial and an expensive failure. Bioclinpharm’s industry-leading team of data management professionals and statisticians is one of the largest in the industry. With real-world experience in adaptive trial designs and the latest data analytics platforms and technologies, we make certain you can not only access, but also examine data at an individual patient level.
Using Insight — our powerful clinical trial management system — you gain access to a real-time snapshot of your trial status at any time. When your trial is complete, Bioclinpharm’s team extracts, analyzes, and interprets your data, then prepares it for presentation to regulatory agencies and the rest of the world.
At the end of the day, our job is to help ensure your entire project team is able to conduct compliant, cost-effective trials. We focus on the intricate details of your study so you can focus on your trial and on providing new therapies to patients around the world.
At Bioclinpharm, we believe in providing high-quality clinical data management to support your drug development needs to get drugs to market as quickly as possible so patients have access to them.
As a niche data-focused CRO, our expertise allows us to focus solely on the data of a clinical trial and enables us to develop trust with long-lasting partnerships.
Our Clinical Data Management services include:
Bioclinpharm’s biostatistics and statistical programming team provides operational and strategic statistics for clinical research and development. Our operational expertise allows us to deliver high-quality statistical output required for every aspect of drug development.
Our services include:
The Bioclinpharm clinical trials team provides a global platform to meet the requirements of our clients. Efficient clinical trial management requires focus on many aspects at the same time.
Managing these complexities requires a great team effort and expertise to ensure that the trial progresses as planned. Our highly experienced Project Managers make sure that the trial is well-organized and timely.
Bioclinpharm has a network of 100+ GCP trained Investigator sites. With excellent rapport with Investigators and Key opinion leaders, we bring a high level of expertise into executing studies. Our site management services include:
Bioclinpharm collaborates with research sites pre-study, during study conduct, and post-study, including during regulatory interactions. We have a strong track record of FDA inspections for patient PK studies.
Since our first Clinical Data Interchange Standards Consortium (CDISC) compliant submission in 2013, Bioclinpharm has been at the forefront of CDISC compliance. Over the last four years, we have built extensive experience across all areas of CDISC implementation, building over 5,000 domains.
Bioclinpharm’s biostatistics and statistical programming team provides operational and strategic statistics for clinical research and development. Our operational expertise allows us to deliver high-quality statistical output required for every aspect of drug development including the statistical material you need for study reports and regulatory responses.
We provide support and advice for pre-clinical studies to ensure the study objective is being fulfilled.
Our input includes clinical study design, sample size calculations, and consultancy advice during the startup of a study.
We offer production of randomizations including production of emergency unblinding envelopes.
We optimize the use of our Consultant Statisticians to ensure innovative approaches to the statistical content of a study to increase the chances of a successful trial.
Using CDISC standards ensures that the data used in the outputs produced complies with regulatory standards.
Using Bioclinpharm standard macros within the SAS ® Programming system ensures increased efficiency when producing outputs.
Modeling the relationship between exposure and response using nonlinear models and nonlinear mixed effect modeling.
Our statistical and medical writing teams collaborate to produce high-quality reports.
We offer unblinded statistical support and advice for Interim Analyses and DSMBs.
Our expert statisticians can advise on potentials for bias during a Meta Analysis as well as on statistical methods to use.
We provide support for the integration of safety and efficacy data prior to regulatory approval.
The regulatory approval process can be daunting, even for the most seasoned team and well-planned project. Regulatory authorities place immense value on clinical trials with comprehensive safety infrastructures. Bioclinpharm’s Strategic Regulatory team is your end-to-end solution for navigating regulatory processes throughout your product’s life cycle.
Our team takes a collaborative approach, creating a personalized strategy that aligns with your business goals and increases your chances of regulatory approval. Whether you are a large company or a small one, we provide expert guidance through every stage of your product’s journey.
Our goal is to mitigate risk and swiftly respond to any crisis to help you avoid the headaches associated with non-compliance. With our team of regulatory investigators and quality professionals, you can trust us to navigate the ever-changing regulatory landscape.
Key Strategic Regulatory Services we offer:
Focus on bringing new treatments to patients while our Strategic Regulatory team handles the regulatory complexities for you.
Our experienced team provides a wide range of medical writing services:
The regulatory approval process can be daunting, even for the most seasoned team and well-planned project. Regulatory authorities are placing increasing value on clinical trials with comprehensive safety infrastructures. Bioclinpharm’s Strategic Regulatory team offers end-to-end support for navigating regulatory processes throughout your product’s life cycle.
Our collaborative approach helps generate a personalized strategy aligned with your business goals, maximizing your chances of regulatory approval. Whether you are a large or small company, we provide guidance through every stage of your product’s journey.
Our goal is to mitigate risk and respond swiftly to crises, helping you avoid non-compliance. Bioclinpharm’s team of regulatory investigators and quality professionals are problem-solvers well-versed in biopharmaceutical, medical device, and diagnostic regulations.
Focus on bringing new treatments to patients while our Strategic Regulatory team navigates the ever-evolving regulatory landscape for you.