Services

Business Development:

MERC'S Business Development (BD) strategy to date is comprised of:

•Principal focus on Sponsors, then CRO's

•Maintain strong relationships with existing clients, with high levels of delivery to generate repeat business.

•Identify and develop new relationships with Sponsors and CRO's that we are not currently working with. Undertake Capabilities Presentations and get MSA's agreed.

•Focus on areas we are already good at and with excellent metrics, whilst developing database and metrics for new areas.

•Concentrate on high value work that is easier to undertake e.g. by reference to patient access, experience, comorbidities, etc.

•Be mindful of developing capacity through expansion of MERC Sites to cope with workload. Traditionally 8 good studies (high volume, value and achievable), annually seem the right level, so BD has to focus on getting the best ones that fit our business aims. Our reactive workflow has been strong hence less need for an all-out proactive approach.

•Provide a strong, value driven proposal through blended rates and a thought-out delivery package.

Regulatory and feasibility:

Our Feasibility and Proposals Team is led by Melandri Eloff, Head of Feasibilities and Proposals.

•MERC has a central dedicated Feasibility Team •Working in close partnership with sites and our senior management team •Early rapid response from sites and contacts for feasibility questionnaires

Timelines:

3-5 days for initial list of sites and estimated enrollment (majority were responded to within 1 day)

10 days for full budget and proposal for awarded studies.

We are looking to:

•Streamline the feasibility process •Proceeding straight to site selection •Providing capabilities slides for each Therapeutic Area Using a Top Down approach with Sponsor/CRO sales teams

Timeline:

Initial Approvals.

Members reported fast approval-65d

Consistency improved

Amendments

Median 2-3 weeks with upper range of 7 weeks.

Additional Investigators

1-5 days (7-14 days in 2018)

Budget and contracts:

Our Contracts and Compliance Team is led by Mohsin Russol, HoD for Contracts & Finance

Budgets

Turnaround time: 5-10 days for full costing, subject to information provided. Ballpark budgets may be quicker.

We provide a central budget with blended rate in our standard template;

Sponsor budgets typically don't include line items for our model & the additional activities undertaken to deliver our premium services.

•Our focus is principally driven by high delivery •Costs per patient are lower than other SMO's •We've aligned our budget presentation so its a familiar format, offering transparency •We offer flexibility and can move costs within the budget to meet client needs We have a pragmatic approach to risk share strategies

Contracting

Turnaround time: typically 2 weeks, subject to sponsor timelines, negotiation of budget and contractual terms.

•Our preferred process is one central contract (within an overarching MSA) covering all sites involved.

•Provides maximum efficiency and facilitates rapid start •We approve the contract within 24hrs of budget approval •Sponsor contract requirements can be accommodated •MERC takes care of all our sites contracting via our own robust contracting structure and processes, thereby saving CRO resource •Amendments are easily managed •Central invoicing - and we pay the sites! •Metrics set up on a national study basis in line with Sponsor expectations.

Project management

Our Programme Management Team is currently led by Dr. MS Tayob assisted by Site Managers. New Head of Programme Management to be appointed.

Study set-up

•One point of contact for Programme Management across all MERC sites •Central 'Essential documentation' collection to expedite start up and reduce admin burden •Central EC management to facilitate speedy submissions •Central oversight on study level training and follow-up •Supplies and SIV coordination

Recruitment

•Continuous lessons learned and mitigation across multiple MERC sites •Patient, Site and client centric approach to study conduct •Weekly reports to provide oversight of all up-front activities •Management of conversion rates throughout the recruitment funnel to ensure low fail rates •Support KPI's for data entry, query resolution, etc. •Escalation point •

Maintenance and close out

•Manage re-consents and protocol amendments Support database lock to ensure deadlines are met

Patient recruitment and retention

"Give us the challenge, we will find the Solution. We have done this repeatedly"

Our Patient Recruitment Team is led by Kagiso Molaetoa

"Recruitment is our passion. We consider ourselves leaders in recruitment! We are 2 x SPRIA award winners for Innovative Recruitment Methods! "

Our Focus

STAKEHOLDER RELATIONSHIPs

Professional - DoH, Clinics and Hospitals

PARTICIPANTS

we are in TOUCH with our communities, our people, our heartbeat

SITES

constant contact with our sites on recruitment challenges, allow us to be proactive and innovative in providing them with recruitment solutions!

TARGETS

We meet our recruitment targets way ahead of the timelines; thus saving costs to the clients

How do we do it?

P2P = Patient 2 Patient

Dedicated Patient Engagement Team (Creative design, central recruitment campaigns and tele screening)
Experienced in patient centric, country specific recruitment materials to engage and recruit patients.
Develop data driven recruitment strategies
Pro-active approach to patient pre-identification for expedited FPI
Experienced and adaptable to working alongside client PR teams to facilitate central campaigns and innovative approaches
Extensive MERC Database of consented patients with their brief medical history - the "TAP" programme

Strong Healthcare Partnership Team working with General Practitioners, Pharmacists, Clinics & Hospitals - government & private Network of Specialists to facilitate referrals
Conventional Recruitment Material - Printed flyers, pamphlets, posters etc.
Digital Marketing - Social media, TV, Video on Demand and Radio based outreach
Community outreach - established "CAB's" = Community Advisory Boards, Door to Door recruitment, Health Awareness Days, Bring a Buddy etc.
Patient engagement initiatives (webcasts, engagement platforms)

Quality management, training and development

MERC's Quality Team is assisted by Sr. Nadia van Den Heever

We have a Dedicated Quality team comprising Quality Defenders (QD's) and Operation Compliance Designees (OCD's)

Quality Assurance

•Internal audits - Focused on inspection readiness - RED FILE •Study vendor and site level audits

Operational Compliance

•Operational Compliance visits performed regularly by Quality Defenders. •Review of monitoring reports to assess trends - FU Letter Training Sessions •Management of Quality Issues (QIs) (root cause analysis, CAPA process) •Supporting client audits/reg inspections

SOP Management and Mandatory Training Licenses Management

•75 SOPs issued to date and controlled Docs (Standardisation of processes) •Training-file Management (Centralized GCP, IATA & Anti Bribery training) •Mandatory training licenses are issued for GCP, IATA, and Anti Bribery courses (completion ensured within required timescales)

Experienced teams and dedicated Data Coordinators who work full time on data entry

•DCs are trained and experienced in all commonly used eCRF and safety reporting systems •Timely data entry and rapid query resolution - metrics to monitor data entry •Close management of database locks - enables timely sponsor data analysis

MERC places high emphasis on quality from its PIs and sites

•Quality management system with adherence to Standard Operating Procedures, implementation and updates •Effective induction, training and supervision of study staff .Visit worksheets clear and consistent. AE and SAE reporting and monitoring .

•Site files maintenance and GCP compliance regularly reviewed •Adherence to ethics and patient confidentiality

•Continual quality reviews and internal audit across sites

•Weekly meetings for quality team and doctors

•Core study team approach for every study

•CMO leadership and hands on approach

•Partnership governance plan also covers quality oversight