What gap in clinical trial technology led to development of specialized mobile infrastructure? A medical organisation approached Inventus with what appeared to be a routine request to source and deploy mobile devices for a clinical trial. The work itself was familiar. Co-Founder and CEO Steve Sanghera, and Co-Founder and Chairman Jim Michel had spent decades in telecommunications, managing mobile infrastructure across industries where systems are expected to perform reliably across geographies, networks and conditions. The assignment fell squarely within that experience. They delivered what was required. But a medical company was not a typical buyer of that scale of mobile infrastructure. It made them wonder: why would a clinical trial depend so heavily on devices not designed for it? Through conversations with trial sites, sponsors and operational teams, they learned that clinical trial devices were consumer-grade and were not built for regulated environments. Inventus chose to address that gap by rebuilding the system. It replaced consumer hardware with purpose-built patient- and site-specific devices designed for clinical trials. These devices introduced a standardised, validated foundation, ensuring that interactions with the study adhered to defined parameters rather than varying across users and environments. That decision established Inventus as the world’s first manufacturer dedicated exclusively to patient- and site-mobile technology for clinical trials, creating an entirely new category that did not previously exist. But solving the device layer exposed a second set of challenges. Once deployed into live trials, performance was no longer defined by the device alone. Data flow depended on connectivity across regions, and device behaviour depended on how it was controlled over time. These variables remained fragmented. Connectivity varied across networks. Control relied on adapting generic systems not designed for clinical protocols. Accountability sat across multiple vendors. The model was extended beyond hardware to build an integrated infrastructure around the device. Connectivity was redefined through Inventus Connect, the world’s first and only clinical data plan operator (CDPO). It ensured consistent, carrier-agnostic communication across geographies. Control was established through Inventus Control, the only mobile device management (MDM) platform purpose-built for clinical trials, enabling devices to operate in alignment with protocol requirements throughout the lifecycle of a study. “If you think about clinical trials as building a plane, sponsors and CROs design the engines and systems. We provide the rivets. Without those rivets, the plane doesn’t fly,” says Sanghera. Building the Missing Infrastructure Behind Clinical Trials How does integrated connectivity and device control improve consistency across global clinical trials? Each device enters the trial already connected. Provisioned with a global eSIM, it does not rely on a single carrier or require manual configuration as it moves across regions. Through Inventus Connect, devices remain connected across more than 150 countries, enabling eCOA data to be collected consistently and securely across borders. Connectivity adjusts in the background, allowing continuous communication regardless of location, while simplifying logistics and supporting reliable, cost-effective data management. Staying connected is only the first layer. Subsequent layers determine how each device is governed. Why is purpose-built mobile device management necessary for maintaining protocol alignment in studies? Before deployment, each device is configured through the MDM layer to align with the protocol of the study. Across Windows, iOS and Android environments, Inventus Control enables the creation and deployment of protocol-aligned settings, approved applications and locked-down controls. What a participant sees and how they interact with the device are defined in advance, ensuring consistency across sites while protecting data integrity. Device status, network connection and data transmission can be monitored in real time. If connectivity drops or behaviour shifts, the device can be accessed remotely and brought back into alignment. Software and application updates are deployed centrally, keeping devices in sync with study requirements without requiring physical intervention.
Drug Discovery and Development
What principles have shaped long-term pharmaceutical development within medically led research organizations? Originality has defined Laboratori Baldacci S.p.A., an Italian pharmaceutical company, for more than a century. Founded in Pisa in 1904 by Dr Valentino Baldacci, it was built on one conviction. Only original, patented compounds validated through its own research earn a place in its portfolio. That principle has endured across generations of Baldacci family leadership, shaped by medical professionals. Pharmacologists, physicians and academic figures have guided its direction, reinforcing a model in which medical thinking drives development. Baldacci operates as a fully integrated organisation, combining internal research, patent-led development, controlled manufacturing and physician-focused scientific engagement. R&D is not a supporting function. It is the core of Baldacci’s identity, shaping how it identifies clinical gaps and strengthens the value of each therapy over time. Its portfolio of more than 10 product patents in more than 20 countries reflects its way of thinking. That structure is what moves differentiated compounds into clinical practice, particularly in gynaecology and neuro-psychiatry. “We don’t put new compounds on the market every year,” explains Marco Bertini, R&D and Medical Affairs Manager. “We try to reinforce the added value of the ones we have.” A Portfolio Built on Clinical Evidence How does integrated pharmaceutical research support development of clinically differentiated medical therapies today? Baldacci has worked with gynaecologists for over 50 years and with neuropsychiatrists for many years, developing original therapies in both areas. Research, chemical, analytical and manufacturing teams work in parallel from the start of each project, resolving formulation, pharmacokinetics and batch standardisati.
Biomanufacturing
Traditional xenografts in bone regeneration largely act as passive fillers, providing structural support but limited biological contribution. Tecnoss® redefines this role through its Dual-Phase bone substitutes, a collagen-based portfolio shaped by more than 25 years of clinical practice and research. Unlike anorganic xenografts, where ceramisation removes the biological matrix and limits regenerative potential, OsteoBiol® by Tecnoss® preserves the native collagen structure within bone granules, enabling active participation in the healing process. This results in a structure composed of hydroxyapatite and ~22 percent collagen that is chemically and physically similar to autogenous bone. By retaining collagen, the biomaterial preserves biological signalling, enabling vascularisation, cellular recruitment and progressive resorption that supports both bone and soft tissue regeneration. Its biomaterial forms are designed for several surgical applications, reducing procedural complexity while limiting invasiveness. Within the portfolio, OsteoBiol® mp3® serves as a graft material that undergoes gradual resorption and is replaced by newly formed bone. OsteoBiol® GTO®, a ready-to-use sticky bone, is changing the way oral surgeons approach horizontal defects, while OsteoBiol® Lamina® provides heterologous cortical collagenic bone for structural support and grafted volume maintenance. “Our biomaterials are designed to benefit patients through improved surgical handling, reduced operative times and minimised procedural invasiveness,” says Giuseppe Oliva, Tecnoss®’s founder..
Clinical Trial Management
When driving innovation in the pharmaceutical industry, accelerating the drug development process is crucial. Dipharma is here to simplify this journey. As a global CDMO and a leading manufacturer of active pharmaceutical ingredients and intermediates, Dipharma turns challenges into opportunities. Instead of juggling multiple CDMOs, Dipharma supports customers as a one-stop partner from pre-IND to market, ensuring seamless compliance in every market. This holistic approach shortens timelines, optimises resources and allows clients to focus on what matters most: delivering life-changing therapies to patients. How does Dipharma make it happen? Its four facilities, strategically located across the U.S. and Europe, are built to satisfy customers’ needs while adhering to the strictest regulatory standards. The three facilities in Italy, certified by Agenzia Italiana del Farmaco (AIFA) on behalf of the European Medicines Agency (EMA), have also earned approval from major regulatory agencies worldwide, most notably the FDA since 1970, the Japanese PMDA, the Korean KFDA and the Brazilian Anvisa. In the U.S., the Kalamazoo-based former Kalexsyn Inc., a world-class contract research organisation (CRO) founded in Michigan in 2003, was acquired by Dipharma in 2018 and underwent a thorough transformation into a small-scale GMP site, culminating in a successful FDA preapproval inspection at early 2024. This harmonised and impeccable compliance track record guarantees every molecule produced at Dipharma’s facilities meets the highest global standards. Transparency Built to Last At Dipharma, client communication is key. They assure every client is always engaged and well-informed. The dedicated team provides daily updates and weekly video calls, fostering seamless communication and collaboration throughout the CDMO project. The core team, including a Project Manager, a Technical Manager and Subject Matter Experts, oversees every phase, maintaining consistency and smooth transitions. The commitment to transparency reflects Dipharma’s dedication to client satisfaction, distinguishing it in the industry as a partner that truly values open collaboration. .
Biobanking
Pioneering Biotech PAT: My Journey with Hamilton Process Analytics
Giovanni Campolongo, Senior Market Segment Manager, Hamilton Bonaduz AG
Therapeutics
Modular approach for Large Scale Cell Culture CDMO facilities
Jacob Gronnegaard, Director Automation, FUJIFILM Diosynth Biotechnologies
CDMO
Navigating the Complexity of Compliance Review of UK/EU Product Communications for Rare Diseases
Marcelo Vaz, Vice President, Medical Services, TMC Pharma Services Ltd
Women's Health
Driving Innovation in Clinical Development: Strategies, Challenges, and the Future
Laura Bonino, Head of Clinical Development, SIFI
Drug Discovery and Development
Navigating the Global Market Access Landscape with Purpose and Passion
Ulf Staginnus, VP of International Market Access & Pricing, Blueprint Medicines
Precision Medicine
The Opioid Pandemic and Enhanced Recovery after Surgery: Eliminating Opioids from Routine Surgical Practice
Dr. Carlos Sandoval-Herrera, Director of Gynecology and Chief of the Division of Minimally Invasive Gynecology, Sinai Chicago
Biotech
Trusted data Foundations for Pharma R&D
Axel Dietrich, Global Head of Data Excellence, CSL
IN MY OPINION
Biotech
Machine-Learning-Generated Insights from Health Data: Promise of Natural Language Processing
Kim Wager, Scientific Director, Oxford PharmaGenesis
LAST WORD
DNA Sequencing
The Next Technological Advancement in Resin Development
Sofie Stille, Vice President of Technology, Cytiva
IN FOCUS
Advancing Personalised Care with Gynaecology and Neuro-Psychiatry Medicine Developments in Europe
Gynaecology and neuro-psychiatry medicine developments in Europe focus on personalised care, advanced diagnostics, digital health technologies, and improved patient outcomes.
Data Management Excellence: Supporting Life Sciences Research Initiatives in Europe
Life science data management services in Europe enable research organisations to improve compliance, drive innovation, optimise operations, and accelerate scientific discoveries globally.
EDITORIAL
Building Structure Behind Modern Life Sciences
At the centre of this issue, Inventus is recognized as the Top Life Science Data Management Service in UK 2026. The company identified a structural gap within clinical trials where consumer-grade mobile systems were being used in highly regulated environments. In response, Inventus built an integrated infrastructure combining purpose-built devices, global connectivity and protocol-aligned mobile device management into a single ecosystem. Its model improves data continuity, operational control and trial consistency across multicountry clinical studies while reducing fragmentation between providers.
A similar emphasis on long-term clinical value defines Laboratori Baldacci S.p.A, recognized as Top Gynecology and Neuro-Psychiatry Medicine Development in Europe 2026. Instead of prioritising rapid portfolio expansion, the company focuses on strengthening the clinical value of patented therapies through ongoing research and physician-led scientific engagement. Its integrated development structure combines research, manufacturing and clinical collaboration to support differentiated therapies across gynaecology and neuro-psychiatry.
Perspectives featured throughout this edition further reinforce these priorities. Dr. Carlos Sandoval-Herrera, Director of Gynecology and Chief of the Division of Minimally Invasive Gynecology at Sinai Chicago, examines how enhanced recovery after surgery protocols and minimally invasive techniques can help reduce opioid dependence and improve patient recovery outcomes. Axel Dietrich, Global Head of Data Excellence at CSL, shares how trusted data foundations, semantic context and governance frameworks are becoming critical to responsible AI adoption and faster pharmaceutical decision-making.
The organisations and leaders featured in this issue reflect how modern life sciences increasingly depend on operational structure, trusted systems and disciplined execution. We invite readers to explore the insights presented throughout this edition.
