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112 www. t e c h n o l o g y r e c o r d . c om

V I EWPO I NT

T

oday’s clinical trials involve more patients,

more sites, more countries and more uncer-

tainty than ever before.The number and com-

plexity of issues affecting the supply chain for these

trials has also grown to include costly comparator

drugs, intricate protocols, delicate investigative

compounds, adaptive clinical trials and variable

dosing schemes. Add in stricter country-specific

regulatory requirements regarding controlled sub-

stances, temperature-sensible products, packaging,

shipping and labelling, and it becomes clear that

supplying drugs for clinical trials involves more

than simply manufacturing them.

To ensure they can rapidly adjust to changing cli-

ent demands during complex and geographically

dispersed clinical trials, life sciences and phar-

maceutical companies need to improve how they

forecast, manufacture and distribute drug supplies.

This can be easily achieved by implementing an

integrated enterprise resource planning (ERP)

solution that can standardise the processes involved

in clinical trial management, while ensuring the

products can be delivered on time, efficiently, and

cost effectively. Integrated ERP solutions can also

synchronise the manufacturing processes for active

pharmaceutical ingredients and drug products

with the demand of dispensable units.

Built on Microsoft Dynamics AX, the AX for

Pharma Clinical Supply Chain module allows

pharmaceutical companies to manage clinical man-

ufacturing,weighing anddispensing, quality control,

inventory, and clinical packaging and labelling pro-

cesses. The platform also enables consistent control

of products, programmes, candidates and protocols.

Aligning drug supply with demand is easy with

AX for Pharma. Users can gain visibility into

demand at a programme, candidate and protocol

level, enabling them to rapidly adjust forecasts

and manufacturing and distribution processes as

changes are made in terms of patient enrolment,

the number of sites and dosing schemes.

Integrated ERP solutions allow supply chain

leaders and project managers to track inventory

and deliveries quickly, which is crucial when a trial

involves investigators and depots in multiple geo-

graphical regions, each with their own import and

export restrictions.

AX for Pharma allows everyone in the supply

chain to track lots and containers as they aremoved

between domestic and international warehouses.

Integrated ERP solutions support the management

of controlled substances, temperature-sensible

products and tamper evidence seals, and facilitate

collaboration with third-party logistics providers.

As clinical trials involve an increasing number

of countries, sites, investigators, patients and

products, integrated ERP solutions, such as AX

for Pharma’s Clinical Supply Chain module, will

become highly valuable for helping companies to

boost efficiency, while remaining compliant.

Massimo Crudeli is the senior manager and

solution architect at AX for Pharma

Streamlining the

clinical supply chain

Integrated enterprise resource planning platforms offer the perfect solution for

successfully managing the supply chain for clinical trials

MA S S I MO C RUDE L I :

AX FOR PHARMA

“Aligning drug supply with demand

is easy with AX for Pharma”