Volunteers
Getting a new drug onto the market is a process that can take many years. BioPharma Services helps companies ensure that drugs that are being developed are safe and effective. Take a look at our Frequently Asked Questions and other volunteer pages to learn more about how you can become involved by participating in a Clinical Trial.
Sponsors
Led by an expert panel of experienced Medical Physicians and Research Scientists, BioPharma has built a full suite of clinical trial solutions from Phase I to BE/BA services to assist our clients’ clinical drug development programs.
We Bring Pharmaceutical Products To Market
The team at BioPharma Services is dedicated to bringing novel therapies to the market through high quality medical research. Founded by the vision of two surgeons dedicated to advancing medical science and improving the life and quality of their patients, we brought life to BioPharma. It is with this same culture and brand of excellence that we welcome our clients.
Our
Services
Along with our core clinical competency of flawless execution of Phase I, BE/BA and Human Abuse Potential studies, complementary support services are available to align with our clients’ clinical trial needs.
As a full-service contract research organization, our service offering includes: Scientific, Medical and Regulatory Affairs, Bioanalysis, Data Management, Biometrics (CDISC compliant data standards), Medical Writing and long-term archiving of study documents.
Why
BioPharma
At BioPharma, we appreciate the dynamic and complex regulatory landscape that governs the drug approval process. Let’s work together to combine our knowledge, expertise, and know-how to navigate our way through the clinical development process and bring first-in-world and affordable medicines to every individual patient in need. With competence and compassion, we as a contract research organization, aim to earn the trust and respect of our global clients, employees, and patients.
Quality and
Governance
In this highly regulated industry that is governed by the international quality standards of GCP and GLP, it is paramount that our processes, quality and governance never falters. With strong adherence to the principles set forth by the ICH, BioPharma’s unwavering commitment to CRO research quality and safety standards is supported by our history of regulatory inspections that spans across markets. This includes routine regulatory inspections by the US FDA, UK MHRA, ANSM, DKMA, ANVISA and Health Canada and a GLP certification by the SCC.
Clinical Trial Services
State of the art facilities. World class leaders. Innovative scientific expertise
Support Services
To ensure the successful submission of every trial, BioPharma offers a full suite of Support Services.
Clinical Trial Services
State of the art facilities. World class leaders. Innovative scientific expertise.
Phase 1 & 2a
We collaborate with global pharmaceutical companies, making sure their program needs for early phase drug development are more than satisfied. BioPharma conducts Phase 1 clinical trials across a wide variety of therapeutic areas.
Bioanalysis
Delivering high quality, accurate and innovative solutions to support the drug development programs of our clients.
Human Abuse Potential
BioPharma has amassed extensive experience in the conduct of clinical studies in opioids, narcotics and cannabinoid products. These studies help drug developers understand their product’s potential risk for abuse before seeking regulatory approval.
Bioequivalence
BioPharma has built a brand of excellence in the conduct of Bioequivalence (BE) and Bioavailability (BA) studies to support both generic and hybrid drug filings and 505(b)(2) New Drug Applications.
Support Services
State of the art facilities. World class leaders. Innovative scientific expertise
Data Management
Efficient, cost-effective services in a timely, expeditious manner packaged to meet the current regulatory and industry standards.
Medical Writing
Our Medical Writing team ensures clear communication between subjects, sites, sponsors and regulatory agencies.
Biometrics/CDISC
With CDISC standards in mind right from data collection, BioPharma offers a suite of biostatistical services.
Scientific Affairs
Our in-house experts have experience over a diverse range of clinical drug development programs for multiple therapeutic areas.
Pharmacokinetics
Under the leadership of Chief Scientific Officer, Dr. John Oldenhof, the PK team have generated thousands of study designs to support drug submissions to multiple regulatory markets.
Recruitment
A fundamental element of success for any clinical trial is subject recruitment. Our extensive database of engaged healthy volunteers includes special populations.
Why BioPharma?
It’s our people, our culture and our community.
Recruitment
CDISC Data Standards
CDISC data standards are becoming standard for all phases of clinical drug development and submissions to the FDA. We have the latest Biometrics Technology to ensure the successful submission of your application.
505(b)(2) NDA
This FDA New Drug Application can be an effective regulatory pathway for new products with well-understood active ingredients. Let us guide you through the process.
Pharmacokinetics
The movement of a drug into, through, and out of the body is a fundamental component of the clinical drug development process. Our expert Pharmacokinetic Scientists have solutions for all drug programs.
Our World Class Management Team
Our world-class team maximizes your results through collaboration.
LOUIS CO
VP of Global Clinical Operations
RENZO DICARLO
Chief Executive Officer
ANNA TAYLOR
Executive VP of Business Development
DR. JOHN OLDENHOF
Chief Scientific Officer
DR. NICKI HUGHES
VP of Lab Operations
JO ANN DI SENSI
VP of Global Quality Assurance and Privacy Officer
BRIAN LUKIAN
Chief Financial OfficerHere's Some Of
Our Achievements
30+
30+Regulatory Inspections
2,000+
2,000+Completed Trials
20+
20+Awards and Recognitions