Required support for recruitment of patients for clinical trials
- In many clinical trials, the amount of time needed to recruit the targeted number of patients is underestimated
- Failure to recruit enough patients in the planned time frame causes delays, additional costs, etc
- Consequently, estimating the recruitment duration is of crucial importance for the proper conduct of the trial
Manual process for recording data was unreliable and expensive
- The client installed accelerometers on mice to record disease events
- The system detected c.100 false positives for each real event
- Results needed to be reviewed and corrected manually by experts
- Data accuracy critical as data set was aimed to be used in pre-clinical trials to compare different treatments
Outsourcing clinical trial safety activities to PharmaLex assures compliance and puts project on track for fast registration
- A US company was dissatisfied with a large global CRO’s study and drug safety management for a programme of multinational clinical trials involving a complex drug device combination therapy. These ongoing studies were pivotal to the successful registration of the treatment in the EU and US. PharmaLexwas given responsibility for all the clinical trial safety activities.
Client in need of expertise for IND development and FDA interaction for First-in-Human study
- European SME beginning first discussions with the FDA regarding IND development and submission of an ADC product for an advanced cancer indication
- Intent to gain agreement on completed nonclinical program to support first in-human (FIH) study
Reluctance to compute tolerance intervals
- Needed support with the preparation of Module 3 and corresponding Module 2.3 documents for drug substances and drug products:
- To reflect the current status of manufacturing process and state of the scientific art analytical procedures
- To close gaps and achieve GMP compliance of regulatory documentation.
- Required on-going lifecycle management for all drug product licences needed.
Market specific CTA applications for a multi-country EU Phase III clinical trial
- Assistance required to review core documentation.
- Authoring of local documentation for country specific submissions.
- Assistance with competent authority and ethics committee communication.
- Support with handling of substantial amendments to competent authorities and ethics committees, as required.
Support for timely approval of a Phase II clinical trial in the US and UK
- Required assistance in IND authoring, eCTD publishing and FDA Agent activities for submission to FDA.
- Alongside support in authoring of IMPD and local documentation required for submission to MHRA.