100+ Year
Pharmacological studies managed by the institution
14.8K+
Individually governed since platform rollout
6
Receipt, availability, quarantine, delivery, return and destruction
25 Years
For trial documentation, audit and inspection
1. The Enterprise Challenge
A leading university hospital and academic medical center in Southern Europe combines high-complexity healthcare, medical education and advanced biomedical research within one institution. Scientific research is a major part of that environment. The organization manages more than 100 pharmacological clinical trials every year, requiring its Centralized Pharmacy to maintain rigorous control over study documentation, investigational-product deliveries, storage conditions, clinical-unit handover and long-term regulatory evidence.
Before the transformation, significant parts of this activity relied on shared spreadsheets, paper documentation and operational records organized around individual deliveries. That made it possible to understand a shipment, but much harder to reconstruct the complete operational history of a clinical trial across many shipments and product movements.
Coopera introduced a different model. The Clinical Trial became the persistent context of the study. Every physical shipment became a connected Delivery Box. Every individual investigational-product package became an independently governed Investigational Product Unit.
Since rollout, 786 Delivery Boxes have introduced 14,757 individually governed Product Units into the environment — almost 19 separately traceable units per shipment on average.
The objective is not simply to know where investigational medication is stored. It is to preserve the relationship between study, regulatory evidence, physical shipment, individual product condition, movement, responsibility and final disposition throughout the life of the trial.
2. Why it was complex
The challenge was not simply to digitize the Trial Master File or manage pharmaceutical inventory. It was to keep regulatory, logistical and physical accountability synchronized around the same clinical study.
The Clinical Trial is larger than its documentation
Study protocols, ethics approval, institutional authorization, contracts and regulatory evidence are essential. But the actual operation also includes Sponsors, Principal Investigators, clinical units, physical shipments, investigational products and the movements of those products over time. The documentary and physical realities have to remain connected.
Accountability reaches the individual package
A shipment can contain many individual packages. Those packages may subsequently follow completely different paths.
- One may become available for clinical use.
- Another may be quarantined.
- Another may be delivered to a clinical unit.
- Another may later be returned or destroyed.
The shipment therefore cannot be the lowest level of accountability.
Safety conditions can change what is legitimate
At receipt, information such as lot, expiry, refrigeration requirements and temperature conditions can materially affect whether an individual Product Unit can be used. A suspected anomaly may make Quarantine the legitimate next condition instead of availability.
Product definition and physical product are different realities
The institution needs reusable knowledge describing what an investigational product is and how it should be handled. But it also needs to know exactly what happened to each physical package received. Those two responsibilities cannot be collapsed into one record.
Evidence must remain reconstructable for decades
Clinical-trial documentation carries a 25-year traceability requirement. Years later, the institution may need to reconstruct what arrived, under which conditions, who verified it, which lot was involved, how its condition changed and whether it was ultimately delivered, returned or destroyed.
That requires operational history, not simply document retention.
3. How Coopera Holds the Operation Together
The environment is built around three connected Living Business Objects, each representing a different dimension of the same clinical-trial reality.
Clinical Trial
The Clinical Trial is the primary persistent operational context. It can keep connected: Study Protocol · Sponsor · Principal Investigator · Clinical Unit · Ethics Committee Approval · Institutional Authorization · Contract · Regulatory Documentation · Delivery Boxes · Investigational Products · Operational History.
Its overall lifecycle can move through: Active · Suspended · Closed. Individual deliveries and product movements can begin and end while the Clinical Trial remains the persistent point of continuity.
Delivery Box
Every physical shipment becomes a Delivery Box connected to its Clinical Trial. It preserves the logistics context of what arrived: Delivery Identifier · Arrival Date & Time · Delivery Documentation · Packing List · Temperature Logger · Shipment Conditions · Received Products · Supporting Evidence.
Its lifecycle can include: Received · Verified · Delivered · Partially Delivered.
The Delivery Box answers a very specific question: What arrived, when, and under which conditions?
It does not determine the subsequent regulatory life of every product contained inside it.
Investigational Product Unit
Every individual physical package becomes an independently governed Investigational Product Unit.
It remains connected both to the Delivery Box through which it arrived and to the product definition describing what it is and how it must be handled.
Its principal controlled states are: Received · Available · Quarantine · Delivered · Returned · Destroyed. These are not reporting labels. They represent the actual regulated condition of the physical product and determine what operations are legitimate. Two Product Units arriving together in the same Box can therefore later represent completely different realities.
The shipment remains connected. The study remains connected. But accountability follows the individual physical unit.
4. What This Looks Like in Practice
Investigational Product Receipt
The shipment arrives. Individual accountability begins. When a delivery reaches the Centralized Pharmacy, the shipment is registered together with the evidence required to understand its condition. This can include: Arrival Date & Time · Delivery Documentation · Number of Packages · Product · Lot · Expiry · Refrigeration Requirements · Temperature.
The Delivery Box provides the common logistics context. But the products contained inside it immediately acquire their own individual operational identities. A shipment containing twenty packages therefore does not become one indivisible inventory event. It creates twenty physical objects whose subsequent conditions can evolve independently.
Quarantine and Product Availability
Safety conditions determine what can happen next. A newly received Investigational Product Unit does not automatically become available for clinical use. Verification determines whether the conditions required for availability are satisfied. A temperature anomaly, documentary inconsistency or other condition requiring further assessment can move the specific Product Unit into Quarantine. Other units from the same shipment can remain unaffected. Once the relevant conditions are resolved, the Product Unit can progress according to its actual situation.
This is an important operational principle: the current condition of the physical product determines which action becomes legitimate next.
Clinical-Unit Delivery
Physical movement remains connected to the trial. An available Product Unit can subsequently be delivered to the clinical unit participating in the study. The handover is not a disconnected warehouse movement.
The Product Unit remains connected to the Clinical Trial, the shipment through which it entered the institution and the evidence associated with its own lifecycle. Processes can guide the handover, perform controls, update its condition and generate the documentation required to formalize what occurred.
The physical product moves. Its operational history remains continuous.
Return or Destruction
Final disposition is part of accountability. An Investigational Product Unit can ultimately be returned to the Sponsor or destroyed according to the applicable conditions. Those events become part of the same persistent product history rather than another independent archive record.
The institution can therefore reconstruct: what was received · what happened to it · where it went · who acted · what its final disposition was without rebuilding the story from shipment spreadsheets and separate documents.
The lifecycle ends. The evidence remains.
5. Operational Events Become Regulatory Evidence
The architecture deliberately separates what happened from the document proving that it happened. Operational information is first recorded in the governed context of the Clinical Trial, Delivery Box or Product Unit. The corresponding document can then be generated as formal evidence of that event. This avoids maintaining one version of reality in operational data and another in manually produced documents.
The event establishes the operational truth. The document formalizes the evidence.
That distinction becomes particularly valuable during audit and regulatory inspection, because the evidence remains connected to the lifecycle event, responsible participant and object condition that produced it. And because clinical-trial traceability must remain reconstructable for 25 years, that relationship remains important long after the physical investigational product itself has completed its lifecycle.
6. The Outcome
The university hospital now operates one digital model connecting clinical-trial governance with the physical and regulatory lifecycle of investigational products.
More than 100 pharmacological studies are managed annually. Since rollout, 786 physical Delivery Boxes have introduced 14,757 individually governed Investigational Product Units into the operational environment.
- Every shipment retains its logistics context.
- Every individual Product Unit maintains its own operational condition.
- Every Unit remains connected to the product definition explaining what it is, the Delivery Box explaining how it arrived and the Clinical Trial explaining why it exists within the institution.
A package can therefore become quarantined, delivered, returned or destroyed independently of the other products received in the same shipment without breaking the traceability of either the shipment or the study. The Clinical Trial continues to connect these physical activities with Sponsor, Principal Investigator, clinical structures and regulatory documentation. Audit evidence therefore does not need to be reconstructed independently from operational history. The same persistent objects that support daily work preserve the information needed for future verification.
The result is not simply an electronic Trial Master File or an investigational-drug inventory. It is a governed digital operational model of the clinical trial and its physical investigational-product reality — connecting regulatory evidence, logistics, individual pharmaceutical units, safety conditions and long-term accountability.
5. What This Case Proves
Regulated physical objects can become Living Business Objects
Each individual Investigational Product Unit can maintain its own condition, history and final disposition while remaining connected to the shipment and clinical study that give it meaning.
Traceability can reach the correct accountability boundary
The individual physical package — not merely the trial or shipment — can become the unit of operational accountability.
Different operational realities do not need to be collapsed into one object
Clinical Trial, Delivery Box and Investigational Product Unit retain distinct responsibilities while their relationships create one coherent regulated operation.
Safety conditions can directly constrain execution
A Product Unit in Quarantine cannot be treated as available. Its current condition determines which subsequent actions are legitimate.
