CalCog Quarterly Update

Q1 2024

Industry Trends: How R&D is Attracting Funding

CalCog is eagerly following the growing number of emerging clinical-phase pharma and biotech companies. From life-saving medicines to life-changing medical devices, their groundbreaking research stands to change the face of medicine.

Once a clinical-phase pharma or biotech company receives funding for its FIH trial, avoiding costly delays is paramount. According to Factors Affecting Success of New Drug Clinical Trials published in the National Center for Biotechnology Information:

Approximately 80% of clinical trials do not meet the initial enrollment goals and timelines, and these delays result in a loss of $8 million in revenue per day for drug discovery companies.

CalCog’s ability to operate with the efficiency and rigor of a large organization while maintaining the agility and personalized attention of a smaller entity makes us an ideal clinical supply provider for start-ups. Our nimble operational model ensures quick decision-making and flexibility, which is critical to supporting our clients’ clinical supply needs and ensuring they meet their first patient in (FPI) for investors.

Learn more about this new wave of groundbreaking research in our article, From Investment to Advancement: How R&D is Attracting Funding.

Behind the Scenes: CalCog A Year in Review

The CalCog team is extremely grateful to have the opportunity to help innovators create a healthier future for patients in need, and we thank our clients, partners, and vendors for being part of our journey.

We had a tremendous 2023, and we are looking forward to an amazing 2024!

CalCog Capability Corner: Schedule I through V Controlled Substance Handling

Our clients know we are a global provider of clinical supply services including packaging, labeling, storage, distribution, and comparator sourcing.

Did you know we also specialize in supporting clinical supply of Schedule I through V drugs?

CalCog recognizes the significant complexities faced in controlled substance clinical trials which is why we offer:


Drug Enforcement Agency (DEA) Registrations
  • Importer Registration Certificate – Schedules I through V
  • Exporter Registration Certificate – Schedules II through V
  • Manufacturer Registration Certificate – Schedules I through V
  • Distributor Registration Certificate – Schedules I through V
Schedule I through V Clinical Services

CalCog’s controlled substance management offering includes:

  • Import / Export and Importer of Record services
  • Ambient and refrigerated cGMP secondary packaging
  • Returns management and destruction services
  • NDC obtainment for Arcos reporting purposes
Secure cGMP Storage

CalCog’s cGMP facility in Texas is equipped with advanced security measures including a 576 square foot DEA-compliant vault with restricted access, surveillance systems, and monitored / controlled temperature environments.

Regulatory Oversight & Compliance

With a deep understanding of the complex DEA regulatory landscape, CalCog provides expertise in navigating the stringent clinical supply regulations associated with depot storage and distribution of controlled substances.

CalCog’s onsite Regulatory team ensures:

  • No paperwork delays
  • Rapid verification and dispatch of clinical supply
  • Power of Attorney for backup
Documentation and Reporting

CalCog ensures comprehensive and accurate record keeping, documentation, and reporting to meet regulatory requirements, including controlled substance dispensation records and maintaining compliance with cGMP and GDP guidelines.

Get to Know the CalCog Team: Alan Tainty, Global Director of Commercial Operations

When and why did you join CalCog?

I joined in March 2017. I was looking to join a company that was client focused, where my voice could be heard, and not a corporate giant where the employees are just numbers. Caligor Rx, as it was then, was developing its clinical trial supply offering, and I was excited to be able to bring my experience to help develop the services. We pride ourselves on our quick response, compliant solutions.

What is your favorite part of working at CalCog?

I really enjoy collaborating with our clients on their studies and seeing the successful outcomes of those collaborations.

What clinical trial supply industry are you most excited about?

Cell and Gene therapies. It comes with all sorts of logistical challenges at the moment, but as we saw through Covid, necessity breeds invention. I look forward to seeing what innovations are realized to support Cell and Gene therapies.

What are three fun facts about you?
  • I’m an avid comic book fan, particularly DC Comics. I have over two thousand comics dating back to the 60s.
  • I lived in Australia from 1968 to 1971, and I have more family living in Australia than I do in the UK.
  • I appeared in the opening credits of a UK TV news program called Exchange Flags. The show ran for several years in the 80s.
I am most proud of...

Like everyone, it would be the birth of my children and grandchildren. Outside of that, I was blessed to be a bone marrow match for a lady in Germany with Leukemia. In 2001, I donated bone marrow, and in 2016, she contacted me. Although we have never met, we have stayed in touch since then.

Who is your personal hero and/or professional mentor?

Other than my father it would be David Attenborough.

Is there anything else you'd like to share?

I have four dogs, all of whom keep me on my toes and get me exercised. Three of our dogs are rescues. Maxx, our white German Shepherd, we purchased from a breeder in 2013. The breeder was runner up in the UK version of the Apprentice.

CalCog Out & About

The CalCog team will be exhibiting at these upcoming conferences:

  • Global Clinical Supplies Group 2024 US Conference: Naples, FL 21Apr2024 – 24Apr2024
  • PEG Precisions in Clinal Trials Summit: Boston, MA 06May2024 – 07May2024
  • Clinical Supply Trial Forum: Brussels, Belgium 14May2024 – 16May2024

Interested in meeting us in person? Schedule a meeting at Trade Show & Conferences | Connect with Us | CalCog.