1. Compliance Issues

‘The company has 3 Form 483s issued in the past 5 years.’
The CRO/CDMO has been found not to comply with GLP/GMP/GCP standards mentioned. The compliant claims are there, but there isn't enough data or documentation to support them. Several Form 483s have been issued to the facility repeatedly.

2. Vague Endpoints

‘The results will be looked at later in case of failures.’
The endpoints are not specified, and alternatives in case of failures are not specified in advance.

3. Vague Timelines

‘The work will be completed in some time.’
The CRO/CDMO doesn’t provide exact deadlines; instead, it provides vague statements about project deadlines. Only the major timeline doesn’t matter; the smaller ones do too, because they add up.

4. Communication Gaps

‘No reply.’
Long gaps between meetings. No updates on delays or failures. Delayed responses and vague answers. Early and regular communication is the key. You should be kept regularly updated on the project, any changes to it, and even its failures.

5. Regulatory Misalignment

‘We don’t have any regulatory affairs personnel.’
Experiments are performed without regulatory alignment. The scientific basis for the process is in place, but it has not been integrated with the regulatory process, which could lead to future approval issues.

6. Staff Transparency

‘We have very well-qualified staff; you don’t need all the information.’
They are not transparent about the status of the technical and non-technical staff working. The staff assigned to the project don’t have a clear division of labour. Changes are being made in the working professionals in short timelines.

7. Sycophant Nature

‘“Yes” is their reply to every demand you make.’
A credible CRO/CDMO will tell you what is feasible and what is a stretch. A yes-man company hasn’t given much thought to the project's complexities.

8. Missing Technicalities

‘We will be procuring all the equipment required after the project starts.’
The equipment and staff are overpromised in terms of qualifications, but the data is not available on paper.

9. Financial Issues

‘We are dependent on your project for the funding completely.’
The CRO/CDMO doesn’t present their financial audits and is too reliant on your project for funding.

10. Underestimating Technical Transfer Complexities

‘Scale-Up will be easily done.’
Tech transfer is a long, tedious task with unexpected challenges at every stage, from lab scale to commercial scale-up.