|
|
|
|
|
|
|
transport between countries. Where a courier covers many countries they may have pricing structures dictated by the country where the pack originates thus making accounting a nightmare and price negotiation virtually impossible. |
|
|
|
|
|
|
|
|
Over the years the laboratory has worked hard towards establishing a good working relationship with one commercial courier company. This company, in turn, has allocated a U.K. based accounts manager specifically to meeting the needs of the laboratory and both parties see the relationship as a working partnership. All transport arrangements and queries are handled through the accounts manager who resolves issues with the regional manager in each European country. The laboratory holds a list of names of key courier staff in each country and in each major European region a member of the local Zeneca staff is nominated to coordinate and resolve local transport arrangements (e.g., collection addresses, courier contact telephone numbers, latest pick-up times, etc.). |
|
|
|
|
|
|
|
|
For the period July 1994 through June 1995 over 8,000 individual samples were transported to the laboratory from 17 European countries; a further 1,953 were delivered from U.K. centers by the mail service. Since the pattern of sample collection reflects the working practices of the investigators, it may be of passing interest that, throughout Europe, investigators see significantly less clinical trial patients on Friday compared to other days. More importantly, the transport times from each European country (collection date to delivery date) are displayed as actuals and percentages in Figures 7a and b. Individual differences exist, which appear to be independent of the distance from the U.K. Overall 6,553 samples arrived the day after collection while a further 2,548 arrived the following day (i.e., 36 hours after the blood was taken). Less than 3% of the samples were more than 60 hours in transit. |
|
|
|
|
|
|
|
|
B. Result Reporting Times |
|
|
|
|
|
|
|
|
The laboratory provides a single patient report that includes the results for all the tests protocolled for that patient visit. A report is automatically generated when all the analyses are complete and authorized but, for specific trials, an interim report will always be printed on the day the samples are received. Each report is faxed to the investigator with faxed copies going to the CRA at headquarters for trial awareness and to the monitoring CRA responsible for the clinical trial center. While the promptness of the reporting will depend on the number of analyses requested, more significant is the requirement to perform endocrine or surrogate marker assays. For 1,053 samples analyzed for a trial requiring only clinical chemistry and hematology, 78% of all completed reports were faxed on the day of sample receipt, a further 11% were faxed the next day. For another trial where 4 peptide hormone assays were requested for each sample, of the 5,777 analyzed, 64% were reported in full and |
|
|
|
|
|
|
|
|
faxed the same day and further 18% were faxed the next day. |
|
|
|
|
|