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Areas of Expertise

 

Our subject matter experts look forward to bringing unique capabilities and approaches to your company, no matter the situation at hand. Whether it’s for a highly specialized task or larger, more diverse tasks, our services are shaped to meet your needs.

Specialties

Specialization, Flexibility, Results

BioPoint’s customized offerings include both strategic leadership and tactical support within the Regulatory, Quality, Clinical, Safety & Surveillance and HEOR / Market Access functions.

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Our Team

Our consultants are highly qualified in their respective functional area. Each is vetted using our proprietary methodology to ensure the integrity of their specific backgrounds in the life sciences industry. Ultimately, our goal is to provide our clients with practical consulting solutions which properly address the situation at hand.

Drug Safety / Pharmacovigilance

In today’s pharmaceutical, biopharmaceutical and medical device product landscape, you can’t afford to miss crucial safety information about your products. From preclinical studies to post-marketing settings, BioPoint has the broad-based experience to provide comprehensive clinical and post-marketed drug safety consulting and pharmacovigilance training services to help you address product safety concerns in a confident, proactive manner.

Regulatory Affairs

The Life Sciences industry is heavily regulated. Medicines would never reach market without the expertise of regulatory professionals to ensure products in development are meeting global regulatory standards. At BioPoint we understand the importance of properly navigating a complex global regulatory arena. We have a diverse global network of regulatory affairs specialists and experts available to support our clients’ development lifecycle from preclinical through product approval.

HEOR

HEOR Consulting from BioPoint provides our clients the ability to address today’s ever increasing demands to make sound evidence based business decisions. The emphasis on local and international Health Technology Assessment and regulatory requirements necessitates robust HEOR planning throughout a product’s life cycle. Our clients need as much data as possible and the most meaningful information to support key internal and external stakeholders.

QA & Compliance

BioPoint understands how important it is to your company that your quality systems work efficiently and comply with the current domestic and international regulatory requirements. As the regulatory landscape around clinical development evolves, it is vital for our clients to meet regulatory expectations and still remain competitive in the marketplace.

Clin-Ops & Biometrics

Life Sciences organizations today are under increasing pressure to conduct clinical trials that show efficacy, safety, cost-effectiveness, and differentiation, often with fewer resources and in less time.

Pharmaceutical companies must deliver safe and efficacious compounds as timely and as cost-effectively as possible. Addressing this central problem requires a clinical competency that can not only quickly and efficiently evaluate the safety and efficacy of potential new products, but also maximize the value of post marketed products.

Clinical Development

Moving a small or large molecule from bench to bedside is a lengthy and resource intensive process that also comes with great risk. Products would never reach market without the expertise of clinical development professionals to address nonclinical and clinical strategy, medical / regulatory writing, and commercialization.

“I’ve worked with agencies where I have to explain basic industry terms every time we open a new consulting position. With BioPoint, the initial intake call is actually productive. They ask intelligent questions about our specific HEOR requirements and then send over two or three well-vetted profiles. It saves a lot of back-and-forth.”

Director, Health Economics & Outcomes Research, mid-size biotech

“…we had a resource gap open up right during an NDA submission. BioPoint was able to source a qualified replacement within a couple of days, which kept our timeline on schedule. We had a minor onboarding issue the first week, but their account team resolved it the same day. They are very straightforward to work with.”

VP, Regulatory Affairs, specialty pharma

“We originally brought on one consultant for a Phase II protocol review, and we’ve since hired three more people through BioPoint. What I appreciate is that they don’t just passively take down a job description. They understand the therapeutic area and ask the right clarifying questions up front so we get the right fit for our team culture.”

Head of Clinical Development, mid-size biotech

“A lot of agencies in this space are completely transactional. You only hear from them when they’re trying to pitch a candidate or sign a contract. BioPoint actually pays attention to the personal side of things, like following up after a family vacation or remembering a birthday. After a while you stop thinking of them as a vendor.”

Senior Director, Program Management, global pharma